Back to resultsEffect of Household Use of Multiple Micronutrient-fortified Bouillon on Micronutrient Status Among Women and Children in Two Districts in the Northern Region of Ghana
Primary Purpose
Vitamin A Deficiency, Iron-deficiency, Folate Deficiency
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Ghana
Study Type
Interventional
Intervention
Multiple micronutrient-fortified bouillon cube
Control bouillon cube (iodine-only)
Sponsored by
About this trial
This is an interventional other trial for Vitamin A Deficiency focused on measuring Micronutrient, Food Fortification,
Eligibility Criteria
Inclusion/exclusion criteria at recruitment (home visit):
Household
Inclusion criteria:
- Head of household provides oral consent for the participation of household members (index participants), and willingness to have study-provided bouillon cubes used in their household for the next 10 months.
Exclusion criteria:
- Reported chronic medical condition requiring frequent blood transfusion (e.g. severe forms of thalassemia) among any household members;
- Current participation of any household member in a clinical trial;
- Reported shrimp, wheat, milk, soy, eggs, celery, fish, or mollusk allergy, or a previous adverse reaction to bouillon by the participant or any member of their household.
Non-pregnant, non-lactating women of reproductive age
Inclusion criteria:
- Non-pregnant non-lactating women of reproductive age (15 - 49 years);
- Signed the informed consent form (or in the case of adolescents 15-17 years of age, unmarried and still living with their parents, assent provided from the index participant and consent from a parent or guardian) ;
- Planning to remain in the study area for the next 10 months;
- Willing to use study-provided bouillon in household cooking for the next 10 months;
- Not planning to become pregnant during the next 10 months.
Exclusion criteria:
- Severe illness warranting immediate hospital referral;
- COVID-19 diagnosis or exposure in the previous two weeks [individual may repeat eligibility assessment after deferral];
- Presence of morbidity symptoms suggesting COVID-19 infection (fever [temperature > 38°C], chills/shaking, dry cough, shortness of breath or difficulty breathing, loss of smell or taste within the past 72 hours) [individual may repeat eligibility assessment after deferral];
- Chronic severe medical condition (e.g. malignancy) or congenital anomalies requiring frequent medical attention or potentially interfering with nutritional status;
- Unable to provide informed consent due to impaired decision-making abilities.
Children 2-5 years of age (24-59 mo)
Inclusion criteria:
- Child 2-5 years of age (24-59 mo);
- Signed informed consent for the child's participation from a parent or guardian;
- Planning to remain in the study area for the next 10 months;
- Caregiver willing to use study-provided bouillon in household cooking for the next 10 months.
Exclusion criteria:
- Severe illness warranting immediate hospital referral;
- COVID-19 diagnosis or exposure in the previous two weeks [individual may repeat eligibility assessment after deferral];
- Presence of morbidity symptoms suggesting COVID-19 infection (fever, [temperature > 38°C], chills/shaking, dry cough, shortness of breath or difficulty breathing, loss of smell or taste within the past 72 hours) [individual may repeat eligibility assessment after deferral];
- Mid-upper arm circumference < 11.5 cm;
- Chronic severe medical condition (e.g. malignancy) or congenital anomalies requiring frequent medical attention or potentially interfering with nutritional status.
Lactating women
Inclusion criteria:
- Non-pregnant women of reproductive age (15 - 49 years), currently breastfeeding a child who is 4-18 months of age;
- Signed the informed consent form (or in the case of adolescents 15-17 years of age, unmarried and still living with their parents, provide assent from the index participant and consent from a parent or guardian);
- Planning to remain in the study area for the next 4 months;
- Planning to breastfeed for the next 4 months;
- Willing to use study-provided bouillon in household cooking for the next 4 months;
- Not planning to become pregnant during the next 4 months.
Exclusion criteria:
- Pregnancy (determined by self-report);
- Severe illness warranting immediate hospital referral;
- COVID-19 diagnosis or exposure in the previous two weeks [individual may repeat eligibility assessment after deferral];
- Presence of morbidity symptoms suggesting COVID-19 infection (fever[temperature > 38°C], chills/shaking, dry cough, shortness of breath or difficulty breathing, loss of smell or taste within the past 72 hours) [individual may repeat eligibility assessment after deferral];
- Chronic severe medical condition (e.g. malignancy) or congenital anomalies requiring frequent medical attention or potentially interfering with nutritional status;
- Unable to provide informed consent due to impaired decision-making abilities.
Exclusion criteria at screening visit for vitamin A isotope dose (WRA only):
Non-pregnant, non-lactating women of reproductive age
- Hemoglobin < 80 g/L at baseline screening visit;
- Severe illness warranting immediate hospital referral;
- COVID-19 diagnosis or exposure in the previous two weeks [individual may repeat eligibility assessment after deferral];
- Presence of morbidity symptoms suggesting COVID-19 infection (fever [temperature > 38°C], chills/shaking, dry cough, shortness of breath or difficulty breathing, loss of smell or taste within the past 72 hours) [individual may repeat eligibility assessment after deferral];
- Recent diarrhea [≥3 liquid or semiliquid stools in 72 hours]) [individual may repeat eligibility assessment after deferral];
- Reported consumption of vitamin A-rich foods (e.g., liver) in the previous 24 hours [individual may repeat eligibility assessment after deferral];
- Pregnancy (as ascertained via urine pregnancy test for human chorionic gonadotropin on the day of isotope dosing);
- Incomplete consumption of vitamin A isotope dose;
- Positive malaria RDT on the day of isotope dosing [individual may repeat eligibility assessment after deferral];
- CRP > 5 mg/L on the day of isotope dosing [individual may repeat eligibility assessment after deferral].
Exclusion criteria at baseline visit:
Non-pregnant, non-lactating women of reproductive age
- Hemoglobin < 80 g/L;
- Severe illness warranting immediate hospital referral;
- COVID-19 diagnosis or exposure in the previous two weeks [individual may repeat eligibility assessment after deferral];
- Presence of morbidity symptoms suggesting COVID-19 infection (fever [temperature > 38°C], chills/shaking, dry cough, shortness of breath or difficulty breathing, loss of smell or taste within the past 72 hours) [individual may repeat eligibility assessment after deferral];
- Pregnancy (determined by self-report).
Children 2-5 years of age
- Hemoglobin < 70 g/L;
- Severe illness warranting immediate hospital referral;
- COVID-19 diagnosis or exposure in the previous two weeks [individual may repeat eligibility assessment after deferral];
- Presence of morbidity symptoms suggesting COVID-19 infection (fever [temperature > 38°C], chills/shaking, dry cough, shortness of breath or difficulty breathing, loss of smell or taste within the past 72 hours) [individual may repeat eligibility assessment after referral];
- Severe acute malnutrition at baseline (weight-for-height Z-score < -3 SD or bilateral oedema).
Lactating women
- Severe illness warranting immediate hospital referral;
- COVID-19 diagnosis or exposure in the previous two weeks [individual may repeat eligibility assessment after deferral];
- Presence of morbidity symptoms suggesting COVID-19 infection (fever [temperature > 38°C], chills/shaking, dry cough, shortness of breath or difficulty breathing, or loss of taste or smell within the past 72 hours) [individual may repeat eligibility assessment after deferral];
- Pregnancy (determined by self-report);
- Cessation of lactation, or planning to discontinue breastfeeding in the next three months.
Exclusion criteria during course of the intervention:
Non-pregnant, non-lactating women of reproductive age
- Pregnancy (determined by self-report);
- Pregnancy (as ascertained via urine pregnancy test for human chorionic gonadotropin at pre-endline isotope dosing).
Lactating women
- Cessation of lactation (determined by self-report);
- Pregnancy (determined by self-report).
Sites / Locations
- University of Ghana
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Multiple micronutrient-fortified bouillon cube
Control bouillon cube (iodine only)
Arm Description
10-gram shrimp-flavoured bouillon cube, fortified with 6 micronutrients Enrolled participants will receive a household bouillon ration for use in daily cooking (ad lib). Bouillon rations will be replenished every 2 weeks for the study duration of 38 weeks (non-pregnant, non-lactating women 15-49 y and children 2-5 y) or 12 weeks (lactating women 15-49 y and 4-18 mo postpartum).
10-gram shrimp-flavoured bouillon cube, fortified with iodine Enrolled participants will receive a household bouillon ration for use in daily cooking (ad lib). Bouillon rations will be replenished every 2 weeks for the study duration of 38 weeks (non-pregnant, non-lactating women 15-49 y and children 2-5 y) or 12 weeks (lactating women 15-49 y and 4-18 mo postpartum).
Outcomes
Primary Outcome Measures
Change in vitamin A status among non-pregnant, non-lactating women
Total body vitamin A stores and estimated liver vitamin A concentration measured by retinol isotope dilution at baseline and endline
Change in vitamin A status among children 2-5 years
Plasma retinol-binding protein (RBP) concentrations, measured at baseline and endline
Change in vitamin A status among lactating women 4-18 mo postpartum
Breast milk vitamin A concentration and vitamin A per gram fat, measured at baseline and endline
Change in iron status among non-pregnant, non-lactating women
Plasma ferritin and soluble transferrin receptor concentrations, and calculated total body iron stores (BIS), measured at baseline and endline
Change in iron status among children 2-5 years
Plasma ferritin and soluble transferrin receptor concentrations, and calculated total body iron stores (BIS), measured at baseline and endline
Change in hemoglobin concentration among non-pregnant, non-lactating women
Hemoglobin concentration measured in venous blood at baseline and endline
Change in hemoglobin concentration among children 2-5 years
Hemoglobin concentration measured in venous blood at baseline and endline
Change in zinc status among non-pregnant, non-lactating women
Plasma zinc measured at baseline and endline
Change in zinc status among children 2-5 years
Plasma zinc measured at baseline and endline
Change in folate status among non-pregnant, non-lactating women
Erythrocyte folate concentrations, calculated from whole blood folate and serum folate concentrations, measured at baseline and endline
Change in folate status among children 2-5 years
Plasma folate concentrations, measured at baseline and endline
Change in vitamin B12 status among non-pregnant, non-lactating women
Plasma vitamin B12 concentrations, measured at baseline and endline
Change in vitamin B12 status among children 2-5 years
Plasma vitamin B12 concentrations, measured at baseline and endline
Change in vitamin B12 status among lactating women 4-18 months postpartum
Breast milk vitamin B12 concentrations, measured at baseline and endline
Secondary Outcome Measures
Average daily household consumption of bouillon
Assessed biweekly by questionnaire, observed stocks, and wrapper counts.
Adherence to study-provided bouillon
Consumption of study-provided bouillon cubes, expressed as percentage of all bouillon consumed by the household, and as percentage of study-provided consumed by the household, assessed biweekly by questionnaire, observed stocks, and wrapper counts
Change in vitamin A status markers among non-pregnant, non-lactating women
Plasma or serum retinol and retinol-binding protein (RBP) concentrations, measured at baseline and endline
Change in serum folate concentration among non-pregnant, non-lactating women
Serum folate concentration, measured at baseline and endline
Change in plasma retinol concentration among children 2-5 years
Measured at baseline and endline
Change in iodine status among non-pregnant, non-lactating women
Urinary iodine concentration, measured at baseline and endline
Change in iodine status among children 2-5 years
Urinary iodine concentration, measured at baseline and endline
Change in iodine status among lactating women 4-18 months postpartum
Urinary iodine concentration, measured at baseline and endline
Change in urinary sodium concentrations among non-pregnant, non-lactating women
Urinary sodium concentration, expressed as sodium:potassium ratio, measured at baseline and endline
Change in inflammation among non-pregnant, non-lactating women
Plasma concentrations of acute phase proteins, measured at baseline and endline
Change in inflammation among children 2-5 years
Plasma concentrations of acute phase proteins, measured at baseline and endline
Change in current or recent malaria among non-pregnant, non-lactating women
Assessed by rapid diagnostic test at baseline and endline
Change in current or recent malaria among children 2-5 years
Assessed by rapid diagnostic test at baseline and endline
Morbidity among non-pregnant, non-lactating women
Cumulative days of symptoms over the study period, assessed by questionnaires administered biweekly
Morbidity among children 2-5 years
Cumulative days of symptoms over the study period, assessed by questionnaires administered biweekly
Morbidity among lactating women 4-18 months postpartum
Cumulative days of symptoms over the study period, assessed by questionnaires administered biweekly
Change in dietary intake among non-pregnant, non-lactating women
Dietary intake of bouillon, salt, fortifiable foods, energy, macronutrients, and micronutrients, assessed by repeated 24-hour dietary recalls at baseline and endline
Change in dietary intake among children 2-5 years
Dietary intake of bouillon, salt, fortifiable foods, energy, macronutrients, and micronutrients, assessed by repeated 24-hour dietary recalls at baseline and endline
Dietary intake among lactating women 4-18 months postpartum
Dietary intake of bouillon, salt, fortifiable foods, energy, macronutrients, and micronutrients, assessed by repeated 24-hour dietary recalls at baseline
Change in anemia among non-pregnant, non-lactating women
Hemoglobin concentrations < 12 g/dL, measured at baseline and endline
Change in anemia among children 2-5 years
Hemoglobin concentrations < 11 g/dL, measured at baseline and endline
Change in micronutrient deficiency among non-pregnant, non-lactating women
Based on biomarkers of micronutrient status (vitamin A, iron, zinc, folate, vitamin B12), measured at baseline and endline
Change in micronutrient deficiency among children 2-5 years
Based on biomarkers of micronutrient status (vitamin A, iron, zinc, folate, vitamin B12), measured at baseline and endline
Change in low milk nutrient concentrations among lactating women 4-18 months postpartum
Based on concentrations of vitamin A and vitamin B12, measured at baseline and endline
Systolic and diastolic blood pressure among non-pregnant, non-lactating women
Assessed by portable device
Hypertension among non-pregnant, non-lactating women
Based on blood pressure measured by portable device
Change in faecal calprotectin concentrations among children 2-5 years
Stool samples collected at baseline and endline
Change in height-for-age Z score and stunting (HAZ < -2) among children 2-5 years
Standing height, standardized using WHO child growth standards
Change in weight-for-height Z score and wasting (WHZ < -2) among children 2-5 years
Standardized using WHO child growth standards
Change in cognitive development among children 2-5 years
Malawi Developmental Assessment Tool (MDAT) scores in 4 domains (gross motor, fine motor, language, social)
Fecal microbiota among children 2-5 years
Stool samples collected at baseline and endline
Change in cognitive development among children 2-5 years
Early Years Toolbox scores at baseline and endline
Full Information
NCT ID
NCT05178407
First Posted
November 29, 2021
Last Updated
January 20, 2023
Sponsor
University of California, Davis
Collaborators
University of Ghana, Newcastle University, Penn State University, Helen Keller International
1. Study Identification
Unique Protocol Identification Number
NCT05178407
Brief Title
Effect of Household Use of Multiple Micronutrient-fortified Bouillon on Micronutrient Status Among Women and Children in Two Districts in the Northern Region of Ghana
Official Title
Effect of Household Use of Multiple Micronutrient-fortified Bouillon on Micronutrient Status Among Women and Children in Two Districts in the Northern Region of Ghana
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 16, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
University of Ghana, Newcastle University, Penn State University, Helen Keller International
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Background: Micronutrient (MN) deficiencies are severe and widespread in West Africa, particularly among young children and women of reproductive age. Bouillon is a promising food fortification vehicle because the product is centrally processed on large scale, consumed by most households in West African countries (even rural, poor households), and consumed by most members of the household in relatively constant amounts. However, several important research questions remain regarding whether the use of fortified bouillon would be feasible and effective for preventing or reducing micronutrient deficiencies in communities where such deficiencies are common. Specifically, no studies have assessed the impacts of multiple micronutrient-fortified bouillon on micronutrient status. The West Africa Condiment Micronutrient Innovation Trial (CoMIT) Project aims to address this gap, to inform future discussions around fortification of bouillon cubes and related products.
Objective: This study aims to assess the impacts of household use of multiple micronutrient-fortified bouillon cubes (containing iodine in addition to vitamin A, folic acid, vitamin B12, iron, and zinc), compared to control bouillon cubes fortified with iodine only, on:
Micronutrient status among women 15-49 years of age and children 2-5 years of age after 9 months of intervention
Hemoglobin concentrations among women 15-49 years of age and children 2-5 years of age after 9 months of intervention
Breast milk micronutrient concentrations among lactating women 4-18 months postpartum after 3 months of intervention
Methods: This randomized, controlled doubly-masked trial will be conducted in the Kumbungu and Tolon districts in the Northern Region of Ghana, where prior data indicate that deficiencies in the selected nutrients are common. Potential participants will be: 1) non-pregnant non-lactating women of reproductive age (15 - 49 years old), 2) children 2-5 years of age, and 3) non-pregnant lactating women 4-18 months postpartum. Eligible participants will be randomly assigned to receive household rations of one of two types of bouillon cubes:
a multiple micronutrient-fortified bouillon cube containing vitamin A, folic acid, vitamin B12, iron, zinc, and iodine, or
a control cube containing iodine only
Each participant's household will receive a specific amount of bouillon cube every 2 weeks, and households will be advised to prepare their meals as usual, using the study-provided cubes. The trial duration will be 9 months (38 weeks) for non-pregnant, non-lactating women and children 2-5 years of age, and 3 months (12 weeks) for lactating women. The primary outcomes will be changes from baseline to endline in concentrations of haemoglobin and biomarkers of micronutrient status. Secondary outcomes will include change in prevalence of anaemia and micronutrient deficiency; dietary intake of bouillon and micronutrients; inflammation, malaria, and morbidity symptoms; and children's anthropometric measures and child development.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin A Deficiency, Iron-deficiency, Folate Deficiency, Vitamin B 12 Deficiency, Zinc Deficiency, Anemia
Keywords
Micronutrient, Food Fortification,
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The two study groups will receive different bouillon formulations in packaging that is identical except for the study group code. Linkage between the study group codes and bouillon formulations will be known only to the bouillon producer and independent codekeepers, and not to the investigators, data collection staff, or participants.
Allocation
Randomized
Enrollment
2408 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Multiple micronutrient-fortified bouillon cube
Arm Type
Experimental
Arm Description
10-gram shrimp-flavoured bouillon cube, fortified with 6 micronutrients
Enrolled participants will receive a household bouillon ration for use in daily cooking (ad lib). Bouillon rations will be replenished every 2 weeks for the study duration of 38 weeks (non-pregnant, non-lactating women 15-49 y and children 2-5 y) or 12 weeks (lactating women 15-49 y and 4-18 mo postpartum).
Arm Title
Control bouillon cube (iodine only)
Arm Type
Placebo Comparator
Arm Description
10-gram shrimp-flavoured bouillon cube, fortified with iodine
Enrolled participants will receive a household bouillon ration for use in daily cooking (ad lib). Bouillon rations will be replenished every 2 weeks for the study duration of 38 weeks (non-pregnant, non-lactating women 15-49 y and children 2-5 y) or 12 weeks (lactating women 15-49 y and 4-18 mo postpartum).
Intervention Type
Dietary Supplement
Intervention Name(s)
Multiple micronutrient-fortified bouillon cube
Intervention Description
Bouillon cube fortified with 80 µg/g folic acid, 1.2 µg/g Vitamin B12, 3 mg/g Zinc (ZnO), 4 mg/g Iron (FePP/citric acid/trisodium citrate), 200 µg/g Vitamin A (retinyl palmitate), 30 µg/g Iodine (KIO3)
Intervention Type
Dietary Supplement
Intervention Name(s)
Control bouillon cube (iodine-only)
Intervention Description
Bouillon cube fortified with 30 µg/g Iodine (KIO3)
Primary Outcome Measure Information:
Title
Change in vitamin A status among non-pregnant, non-lactating women
Description
Total body vitamin A stores and estimated liver vitamin A concentration measured by retinol isotope dilution at baseline and endline
Time Frame
38 weeks
Title
Change in vitamin A status among children 2-5 years
Description
Plasma retinol-binding protein (RBP) concentrations, measured at baseline and endline
Time Frame
38 weeks
Title
Change in vitamin A status among lactating women 4-18 mo postpartum
Description
Breast milk vitamin A concentration and vitamin A per gram fat, measured at baseline and endline
Time Frame
12 weeks
Title
Change in iron status among non-pregnant, non-lactating women
Description
Plasma ferritin and soluble transferrin receptor concentrations, and calculated total body iron stores (BIS), measured at baseline and endline
Time Frame
38 weeks
Title
Change in iron status among children 2-5 years
Description
Plasma ferritin and soluble transferrin receptor concentrations, and calculated total body iron stores (BIS), measured at baseline and endline
Time Frame
38 weeks
Title
Change in hemoglobin concentration among non-pregnant, non-lactating women
Description
Hemoglobin concentration measured in venous blood at baseline and endline
Time Frame
38 weeks
Title
Change in hemoglobin concentration among children 2-5 years
Description
Hemoglobin concentration measured in venous blood at baseline and endline
Time Frame
38 weeks
Title
Change in zinc status among non-pregnant, non-lactating women
Description
Plasma zinc measured at baseline and endline
Time Frame
38 weeks
Title
Change in zinc status among children 2-5 years
Description
Plasma zinc measured at baseline and endline
Time Frame
38 weeks
Title
Change in folate status among non-pregnant, non-lactating women
Description
Erythrocyte folate concentrations, calculated from whole blood folate and serum folate concentrations, measured at baseline and endline
Time Frame
38 weeks
Title
Change in folate status among children 2-5 years
Description
Plasma folate concentrations, measured at baseline and endline
Time Frame
38 weeks
Title
Change in vitamin B12 status among non-pregnant, non-lactating women
Description
Plasma vitamin B12 concentrations, measured at baseline and endline
Time Frame
38 weeks
Title
Change in vitamin B12 status among children 2-5 years
Description
Plasma vitamin B12 concentrations, measured at baseline and endline
Time Frame
38 weeks
Title
Change in vitamin B12 status among lactating women 4-18 months postpartum
Description
Breast milk vitamin B12 concentrations, measured at baseline and endline
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Average daily household consumption of bouillon
Description
Assessed biweekly by questionnaire, observed stocks, and wrapper counts.
Time Frame
38 weeks
Title
Adherence to study-provided bouillon
Description
Consumption of study-provided bouillon cubes, expressed as percentage of all bouillon consumed by the household, and as percentage of study-provided consumed by the household, assessed biweekly by questionnaire, observed stocks, and wrapper counts
Time Frame
38 weeks
Title
Change in vitamin A status markers among non-pregnant, non-lactating women
Description
Plasma or serum retinol and retinol-binding protein (RBP) concentrations, measured at baseline and endline
Time Frame
38 weeks
Title
Change in serum folate concentration among non-pregnant, non-lactating women
Description
Serum folate concentration, measured at baseline and endline
Time Frame
38 weeks
Title
Change in plasma retinol concentration among children 2-5 years
Description
Measured at baseline and endline
Time Frame
38 weeks
Title
Change in iodine status among non-pregnant, non-lactating women
Description
Urinary iodine concentration, measured at baseline and endline
Time Frame
38 weeks
Title
Change in iodine status among children 2-5 years
Description
Urinary iodine concentration, measured at baseline and endline
Time Frame
38 weeks
Title
Change in iodine status among lactating women 4-18 months postpartum
Description
Urinary iodine concentration, measured at baseline and endline
Time Frame
12 weeks
Title
Change in urinary sodium concentrations among non-pregnant, non-lactating women
Description
Urinary sodium concentration, expressed as sodium:potassium ratio, measured at baseline and endline
Time Frame
38 weeks
Title
Change in inflammation among non-pregnant, non-lactating women
Description
Plasma concentrations of acute phase proteins, measured at baseline and endline
Time Frame
38 weeks
Title
Change in inflammation among children 2-5 years
Description
Plasma concentrations of acute phase proteins, measured at baseline and endline
Time Frame
38 weeks
Title
Change in current or recent malaria among non-pregnant, non-lactating women
Description
Assessed by rapid diagnostic test at baseline and endline
Time Frame
38 weeks
Title
Change in current or recent malaria among children 2-5 years
Description
Assessed by rapid diagnostic test at baseline and endline
Time Frame
38 weeks
Title
Morbidity among non-pregnant, non-lactating women
Description
Cumulative days of symptoms over the study period, assessed by questionnaires administered biweekly
Time Frame
38 weeks
Title
Morbidity among children 2-5 years
Description
Cumulative days of symptoms over the study period, assessed by questionnaires administered biweekly
Time Frame
38 weeks
Title
Morbidity among lactating women 4-18 months postpartum
Description
Cumulative days of symptoms over the study period, assessed by questionnaires administered biweekly
Time Frame
12 weeks
Title
Change in dietary intake among non-pregnant, non-lactating women
Description
Dietary intake of bouillon, salt, fortifiable foods, energy, macronutrients, and micronutrients, assessed by repeated 24-hour dietary recalls at baseline and endline
Time Frame
38 weeks
Title
Change in dietary intake among children 2-5 years
Description
Dietary intake of bouillon, salt, fortifiable foods, energy, macronutrients, and micronutrients, assessed by repeated 24-hour dietary recalls at baseline and endline
Time Frame
38 weeks
Title
Dietary intake among lactating women 4-18 months postpartum
Description
Dietary intake of bouillon, salt, fortifiable foods, energy, macronutrients, and micronutrients, assessed by repeated 24-hour dietary recalls at baseline
Time Frame
4 weeks
Title
Change in anemia among non-pregnant, non-lactating women
Description
Hemoglobin concentrations < 12 g/dL, measured at baseline and endline
Time Frame
38 weeks
Title
Change in anemia among children 2-5 years
Description
Hemoglobin concentrations < 11 g/dL, measured at baseline and endline
Time Frame
38 weeks
Title
Change in micronutrient deficiency among non-pregnant, non-lactating women
Description
Based on biomarkers of micronutrient status (vitamin A, iron, zinc, folate, vitamin B12), measured at baseline and endline
Time Frame
38 weeks
Title
Change in micronutrient deficiency among children 2-5 years
Description
Based on biomarkers of micronutrient status (vitamin A, iron, zinc, folate, vitamin B12), measured at baseline and endline
Time Frame
38 weeks
Title
Change in low milk nutrient concentrations among lactating women 4-18 months postpartum
Description
Based on concentrations of vitamin A and vitamin B12, measured at baseline and endline
Time Frame
12 weeks
Title
Systolic and diastolic blood pressure among non-pregnant, non-lactating women
Description
Assessed by portable device
Time Frame
38 weeks
Title
Hypertension among non-pregnant, non-lactating women
Description
Based on blood pressure measured by portable device
Time Frame
38 weeks
Title
Change in faecal calprotectin concentrations among children 2-5 years
Description
Stool samples collected at baseline and endline
Time Frame
38 weeks
Title
Change in height-for-age Z score and stunting (HAZ < -2) among children 2-5 years
Description
Standing height, standardized using WHO child growth standards
Time Frame
38 weeks
Title
Change in weight-for-height Z score and wasting (WHZ < -2) among children 2-5 years
Description
Standardized using WHO child growth standards
Time Frame
38 weeks
Title
Change in cognitive development among children 2-5 years
Description
Malawi Developmental Assessment Tool (MDAT) scores in 4 domains (gross motor, fine motor, language, social)
Time Frame
38 weeks
Title
Fecal microbiota among children 2-5 years
Description
Stool samples collected at baseline and endline
Time Frame
38 weeks
Title
Change in cognitive development among children 2-5 years
Description
Early Years Toolbox scores at baseline and endline
Time Frame
38 weeks
Other Pre-specified Outcome Measures:
Title
Household food security
Description
Assessed monthly using the Household Food Insecurity and Access Scale (HFIAS)
Time Frame
38 weeks
Title
Household water security
Description
Assessed monthly by the Household Water Insecurity Experience Scale (HWISE)
Time Frame
38 weeks
Title
Change in weight-for-age Z score and underweight (WAZ < -2) among children 2-5 years
Description
Standardized using WHO child growth standards
Time Frame
38 weeks
Title
Change in zinc protoporphyrin (ZPP) concentrations
Description
Measured by portable device
Time Frame
38 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion/exclusion criteria at recruitment (home visit):
Household
Inclusion criteria:
- Head of household provides oral consent for the participation of household members (index participants), and willingness to have study-provided bouillon cubes used in their household for the next 10 months.
Exclusion criteria:
Reported chronic medical condition requiring frequent blood transfusion (e.g. severe forms of thalassemia) among any household members;
Current participation of any household member in a clinical trial;
Reported shrimp, wheat, milk, soy, eggs, celery, fish, or mollusk allergy, or a previous adverse reaction to bouillon by the participant or any member of their household.
Non-pregnant, non-lactating women of reproductive age
Inclusion criteria:
Non-pregnant non-lactating women of reproductive age (15 - 49 years);
Signed the informed consent form (or in the case of adolescents 15-17 years of age, unmarried and still living with their parents, assent provided from the index participant and consent from a parent or guardian) ;
Planning to remain in the study area for the next 10 months;
Willing to use study-provided bouillon in household cooking for the next 10 months;
Not planning to become pregnant during the next 10 months.
Exclusion criteria:
Severe illness warranting immediate hospital referral;
COVID-19 diagnosis or exposure in the previous two weeks [individual may repeat eligibility assessment after deferral];
Presence of morbidity symptoms suggesting COVID-19 infection (fever [temperature > 38°C], chills/shaking, dry cough, shortness of breath or difficulty breathing, loss of smell or taste within the past 72 hours) [individual may repeat eligibility assessment after deferral];
Chronic severe medical condition (e.g. malignancy) or congenital anomalies requiring frequent medical attention or potentially interfering with nutritional status;
Unable to provide informed consent due to impaired decision-making abilities.
Children 2-5 years of age (24-59 mo)
Inclusion criteria:
Child 2-5 years of age (24-59 mo);
Signed informed consent for the child's participation from a parent or guardian;
Planning to remain in the study area for the next 10 months;
Caregiver willing to use study-provided bouillon in household cooking for the next 10 months.
Exclusion criteria:
Severe illness warranting immediate hospital referral;
COVID-19 diagnosis or exposure in the previous two weeks [individual may repeat eligibility assessment after deferral];
Presence of morbidity symptoms suggesting COVID-19 infection (fever, [temperature > 38°C], chills/shaking, dry cough, shortness of breath or difficulty breathing, loss of smell or taste within the past 72 hours) [individual may repeat eligibility assessment after deferral];
Mid-upper arm circumference < 11.5 cm;
Chronic severe medical condition (e.g. malignancy) or congenital anomalies requiring frequent medical attention or potentially interfering with nutritional status.
Lactating women
Inclusion criteria:
Non-pregnant women of reproductive age (15 - 49 years), currently breastfeeding a child who is 4-18 months of age;
Signed the informed consent form (or in the case of adolescents 15-17 years of age, unmarried and still living with their parents, provide assent from the index participant and consent from a parent or guardian);
Planning to remain in the study area for the next 4 months;
Planning to breastfeed for the next 4 months;
Willing to use study-provided bouillon in household cooking for the next 4 months;
Not planning to become pregnant during the next 4 months.
Exclusion criteria:
Pregnancy (determined by self-report);
Severe illness warranting immediate hospital referral;
COVID-19 diagnosis or exposure in the previous two weeks [individual may repeat eligibility assessment after deferral];
Presence of morbidity symptoms suggesting COVID-19 infection (fever[temperature > 38°C], chills/shaking, dry cough, shortness of breath or difficulty breathing, loss of smell or taste within the past 72 hours) [individual may repeat eligibility assessment after deferral];
Chronic severe medical condition (e.g. malignancy) or congenital anomalies requiring frequent medical attention or potentially interfering with nutritional status;
Unable to provide informed consent due to impaired decision-making abilities.
Exclusion criteria at screening visit for vitamin A isotope dose (WRA only):
Non-pregnant, non-lactating women of reproductive age
Hemoglobin < 80 g/L at baseline screening visit;
Severe illness warranting immediate hospital referral;
COVID-19 diagnosis or exposure in the previous two weeks [individual may repeat eligibility assessment after deferral];
Presence of morbidity symptoms suggesting COVID-19 infection (fever [temperature > 38°C], chills/shaking, dry cough, shortness of breath or difficulty breathing, loss of smell or taste within the past 72 hours) [individual may repeat eligibility assessment after deferral];
Recent diarrhea [≥3 liquid or semiliquid stools in 72 hours]) [individual may repeat eligibility assessment after deferral];
Reported consumption of vitamin A-rich foods (e.g., liver) in the previous 24 hours [individual may repeat eligibility assessment after deferral];
Pregnancy (as ascertained via urine pregnancy test for human chorionic gonadotropin on the day of isotope dosing);
Incomplete consumption of vitamin A isotope dose;
Positive malaria RDT on the day of isotope dosing [individual may repeat eligibility assessment after deferral];
CRP > 5 mg/L on the day of isotope dosing [individual may repeat eligibility assessment after deferral].
Exclusion criteria at baseline visit:
Non-pregnant, non-lactating women of reproductive age
Hemoglobin < 80 g/L;
Severe illness warranting immediate hospital referral;
COVID-19 diagnosis or exposure in the previous two weeks [individual may repeat eligibility assessment after deferral];
Presence of morbidity symptoms suggesting COVID-19 infection (fever [temperature > 38°C], chills/shaking, dry cough, shortness of breath or difficulty breathing, loss of smell or taste within the past 72 hours) [individual may repeat eligibility assessment after deferral];
Pregnancy (determined by self-report).
Children 2-5 years of age
Hemoglobin < 70 g/L;
Severe illness warranting immediate hospital referral;
COVID-19 diagnosis or exposure in the previous two weeks [individual may repeat eligibility assessment after deferral];
Presence of morbidity symptoms suggesting COVID-19 infection (fever [temperature > 38°C], chills/shaking, dry cough, shortness of breath or difficulty breathing, loss of smell or taste within the past 72 hours) [individual may repeat eligibility assessment after referral];
Severe acute malnutrition at baseline (weight-for-height Z-score < -3 SD or bilateral oedema).
Lactating women
Severe illness warranting immediate hospital referral;
COVID-19 diagnosis or exposure in the previous two weeks [individual may repeat eligibility assessment after deferral];
Presence of morbidity symptoms suggesting COVID-19 infection (fever [temperature > 38°C], chills/shaking, dry cough, shortness of breath or difficulty breathing, or loss of taste or smell within the past 72 hours) [individual may repeat eligibility assessment after deferral];
Pregnancy (determined by self-report);
Cessation of lactation, or planning to discontinue breastfeeding in the next three months.
Exclusion criteria during course of the intervention:
Non-pregnant, non-lactating women of reproductive age
Pregnancy (determined by self-report);
Pregnancy (as ascertained via urine pregnancy test for human chorionic gonadotropin at pre-endline isotope dosing).
Lactating women
Cessation of lactation (determined by self-report);
Pregnancy (determined by self-report).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reina Engle-Stone, PhD
Organizational Affiliation
Department of Nutrition, UC Davis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seth Adu-Afarwuah, PhD
Organizational Affiliation
University of Ghana
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ghana
City
Accra
Country
Ghana
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
The investigators will commit to Global Access. The investigators intend to 1) publish journal articles describing the study results with an Open Access license, 2) make available information about study methods, such as protocols or standard operating procedures, on the study website, and 3) make available de-identified datasets upon request by the study sponsor or other investigators. Material/DataTransfer Agreements will be developed between study collaborators, sponsor, and any organizations that may request the data; terms of the agreement will be subject to the data handling and storage procedures approved by the University of California, Davis Institutional Review Board (IRB) and Ghana Health Services Ethical Review Committee (GHS-ERC). Organizations that may request the data; terms of the agreement will be subject to the data handling and storage procedures approved by the University of California, Davis IRB and GHS-ERC.
Learn more about this trial
Effect of Household Use of Multiple Micronutrient-fortified Bouillon on Micronutrient Status Among Women and Children in Two Districts in the Northern Region of Ghana
We'll reach out to this number within 24 hrs