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
Vitamin A Deficiency, Iron-deficiency, Folate Deficiency
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
Experimental
Placebo Comparator
Multiple micronutrient-fortified bouillon cube
Control bouillon cube (iodine only)
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).