The Effect of Fortified Growing-up Milk on Growth and Micronutrient Status of Nigerian Toddlers (GaGA)
Primary Purpose
Malnutrition; Mild, Iron-deficiency Anemia, Nutritional Stunting
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fortified milk Powder
Sponsored by
About this trial
This is an interventional treatment trial for Malnutrition; Mild
Eligibility Criteria
Inclusion Criteria:
- Normal term birth (caesarean section excluded)
- Boys and girls in the age range of 12 to 36 months at enrolment
- Apparently healthy at screening (assessed with the use of a medical history record)
- Hb ≥70 g/L and ≤109 g/L, according to WHO guidelines 27
- Mild to moderate acute malnutrition (i.e. HAZ, WAZ <-1 SD and > -3 SD)
- Parents and/or legal guardians are residents of Oshodi LGA
- Parents and/or legal guardians do not plan to migrate during the study
- Written informed consent from parents and/or legal guardians
- Children able to consume a maximum of 96g (= 600 ml) of product per day
Exclusion Criteria:
- Severe anaemia (Hb<70 g/L) or normal Hb (Hb≥110 g/L)
- Severe acute malnutrition (HAZ, WAZ <-3 SD) requiring hospitalization
- Chronic or severe illness requiring hospitalisation and/or special treatment
- Recent medical history (past 3 months) of serious infections, injuries and/or surgeries
- Any known allergies or intolerances to milk or milk ingredients
- Predominantly breast-fed infants or toddlers
- Consumption of any other fortified foods or supplements
- Participation to other micronutrient supplementation programmes
- Participation to any other nutritional study in the last 6 months
- Participation to another clinical study or receipt of an investigational drug in the last 30 days
- Indication that they are likely to move within the period of study intervention
- Family members of employees of the Sponsor or the study site.
- Use of any prescription medications prior to and/or during the study period for more than or equal to two weeks.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
200ml
400ml
600ml
Arm Description
Toddlers will be allocated to the 200 ml group
Toddlers will be allocated to the 400 ml group
Toddlers will be allocated to the 600 ml
Outcomes
Primary Outcome Measures
Iron deficiency anaemia
Prevalence of Iron deficiency anaemia as assessed by haemoglobin concentration
Secondary Outcome Measures
Hematocrit
Hematocrit to substantiate the effect of iron supplementation on Hb
Ferritin
ferritin to substantiate the effect of iron supplementation on Hb concentration
plasma concentrations of specific inflammation markers (i.e. C-Reactive)
plasma concentrations of specific inflammation markers (i.e. C-Reactive)
Weight
Body weight for infants up to 24 months old
Serum concentrations of specific micronutrient status
Serum concentrations of specific micronutrient status indices, such as vitamins, minerals and trace elements.
Parameters of cognitive development
Parameters of cognitive development such as Memory tests, attention tests,using screening version of the Bayley III Test for Children
Recumbent length
Length in meters and standing height for toddlers from 24 to 36 months old
Plasma concentrations of specific micronutrient status
Plasma concentrations of specific micronutrient status indices, such as vitamins, minerals and trace elements.
Urine concentrations of specific micronutrient status
Urine concentrations of specific micronutrient status indices, such as vitamins, minerals and trace elements.
Full Information
NCT ID
NCT03411590
First Posted
December 11, 2017
Last Updated
January 26, 2018
Sponsor
FrieslandCampina WAMCO Nigeria PLC
Collaborators
Lagos State University
1. Study Identification
Unique Protocol Identification Number
NCT03411590
Brief Title
The Effect of Fortified Growing-up Milk on Growth and Micronutrient Status of Nigerian Toddlers
Acronym
GaGA
Official Title
The Effect of Fortified Growing-up Milk on Growth and Micronutrient Status of Nigerian Toddlers
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 5, 2018 (Anticipated)
Primary Completion Date
September 8, 2018 (Anticipated)
Study Completion Date
January 24, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FrieslandCampina WAMCO Nigeria PLC
Collaborators
Lagos State University
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
It is well known than an important part of Nigerian children from the lower social economic class have nutrient deficiencies. Fortified products, such as growing up milks (GUM), may play an important role in reducing the risk and incidence of nutrient deficiencies. However, affordability of GUM is an issue.
In this project the effects are studied of different daily intakes of GUM on iron status, growth, several other nutrient status parameters in blood and urine, cognitive development, and the intestinal microbiome in Nigerian toddlers 1-3 years of age.
The project is a collaboration with the department of Paediatrics and Child health of the Lagos State University College of Medicine in Lagos. The design is based on a three-arm, open (partly blind: statistics, biochemical analyses), randomized intervention trial. Recruitment will take place in Ijora-Badia community in Apapa-Iganmu Local Council Development Area (LCDA) in Lagos. The three groups will be given a multi-micronutrient fortified growing-up milk (PEAK), in amounts of 200, 400 or 600 ml per day during a period of 6 months. Primary objective of this study is to reduce iron deficiency anemia. Based on this objective, in total 150 children have to be included in this study.
Detailed Description
The present study will be a three-arm, open (partly blind) blind, randomized intervention trial in Nigerian children (12-36 months of age). Recruitment will take place in Ijora-Badia community in Apapa-Iganmu Local Council Development Area (LCDA), Lagos, South-West Nigeria. Ijora-Badia community has the highest burden of under-nutrition; In addition, it consists predominantly of low to middle socioeconomic status population, which is nationally representative, thus making it an ideal choice for this study. All families that are permanent residents of Ijora-Badia and have children aged 12-36 months will be invited to participate in the study. Before screening and recruitment will take place, parents or legal guardians of all potential candidates (toddlers) will be fully informed about the study, requirements and procedures. This means that at the day of screening, recruitment and enrolment, 10-20 children per day, fulfilling inclusion criteria, will be directly assigned to one of the three study groups when a written informed consent is obtained from the parents or legal guardians.
At the day of screening and recruitment, mothers will be required to bring their child to the clinic. At this initial screening toddlers will be evaluated to assess their eligibility for participation to the study according to the inclusion and exclusion criteria (i.e. anthropometric measurements, blood collection for the assessment of haemoglobin levels and information collected by parents). Those toddlers meeting all inclusion criteria will be considered as eligible and will be randomised to one of the three study groups. Prior to the initiation of the intervention, all eligible study participants will be dewormed (medicine, brand, dosage). Baseline measurements will take place that same day, and after 6 months of intervention: anthropometric measurement, a cognitive test (30 minutes), and venous blood sampling (8 ml). For food and nutrient intake indices, and faecal sampling, a proper planning will be made, to be sure that it takes place within 3 days following baseline measurements.
The three groups will be given a multi-micronutrient fortified growing-up milk, in amounts of 200, 400 or 600 ml per day. In case of 400 and 600 ml, the portions (200 ml each) will be spread during the day. Airtight packed portions of milk powder sachets will be delivered weekly at the families by field monitors who also provide instructions for use as well as collect empty sachets for a compliance check. Consumption of test product will start as soon as all baseline examinations and samples have been completed and collected, and will last for 6 months.
Prior to the initiation of the screening and recruitment phase, the study protocol will have to be approved by the Lagos State University Teaching Hospital Research/Ethics Committee, and has to be registered in an acknowledged trial register.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition; Mild, Iron-deficiency Anemia, Nutritional Stunting, Nutritional Wasting, Nutritional Deficiency, Enterobacteriaceae Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
200ml
Arm Type
Other
Arm Description
Toddlers will be allocated to the 200 ml group
Arm Title
400ml
Arm Type
Other
Arm Description
Toddlers will be allocated to the 400 ml group
Arm Title
600ml
Arm Type
Other
Arm Description
Toddlers will be allocated to the 600 ml
Intervention Type
Other
Intervention Name(s)
Fortified milk Powder
Intervention Description
Toddlers will be allocated to the 200 ml group and will receive on a daily basis 32g of growing up milk powder respectively, in doses of 16 g, which can be reconstituted with 180 ml water to a final volume of about 200 ml of milk. The intervention period will last for 6 months. For the 200 ml test group, this translates into 32 g of growing up milk powder supply as one dose per day (in the morning)
Primary Outcome Measure Information:
Title
Iron deficiency anaemia
Description
Prevalence of Iron deficiency anaemia as assessed by haemoglobin concentration
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Hematocrit
Description
Hematocrit to substantiate the effect of iron supplementation on Hb
Time Frame
6 months
Title
Ferritin
Description
ferritin to substantiate the effect of iron supplementation on Hb concentration
Time Frame
6 months
Title
plasma concentrations of specific inflammation markers (i.e. C-Reactive)
Description
plasma concentrations of specific inflammation markers (i.e. C-Reactive)
Time Frame
6 months
Title
Weight
Description
Body weight for infants up to 24 months old
Time Frame
6 months
Title
Serum concentrations of specific micronutrient status
Description
Serum concentrations of specific micronutrient status indices, such as vitamins, minerals and trace elements.
Time Frame
6 Months
Title
Parameters of cognitive development
Description
Parameters of cognitive development such as Memory tests, attention tests,using screening version of the Bayley III Test for Children
Time Frame
6 Months
Title
Recumbent length
Description
Length in meters and standing height for toddlers from 24 to 36 months old
Time Frame
6 months
Title
Plasma concentrations of specific micronutrient status
Description
Plasma concentrations of specific micronutrient status indices, such as vitamins, minerals and trace elements.
Time Frame
6 months
Title
Urine concentrations of specific micronutrient status
Description
Urine concentrations of specific micronutrient status indices, such as vitamins, minerals and trace elements.
Time Frame
6 Months
Other Pre-specified Outcome Measures:
Title
intestinal microbiome
Description
intestinal microbiome in a subpopulation of infants to explore the effect of 2-7 mg of Fe per day (provided as ferrous-sulfate) on the numbers of and changes in Enterobacteriaceae
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Normal term birth (caesarean section excluded)
Boys and girls in the age range of 12 to 36 months at enrolment
Apparently healthy at screening (assessed with the use of a medical history record)
Hb ≥70 g/L and ≤109 g/L, according to WHO guidelines 27
Mild to moderate acute malnutrition (i.e. HAZ, WAZ <-1 SD and > -3 SD)
Parents and/or legal guardians are residents of Oshodi LGA
Parents and/or legal guardians do not plan to migrate during the study
Written informed consent from parents and/or legal guardians
Children able to consume a maximum of 96g (= 600 ml) of product per day
Exclusion Criteria:
Severe anaemia (Hb<70 g/L) or normal Hb (Hb≥110 g/L)
Severe acute malnutrition (HAZ, WAZ <-3 SD) requiring hospitalization
Chronic or severe illness requiring hospitalisation and/or special treatment
Recent medical history (past 3 months) of serious infections, injuries and/or surgeries
Any known allergies or intolerances to milk or milk ingredients
Predominantly breast-fed infants or toddlers
Consumption of any other fortified foods or supplements
Participation to other micronutrient supplementation programmes
Participation to any other nutritional study in the last 6 months
Participation to another clinical study or receipt of an investigational drug in the last 30 days
Indication that they are likely to move within the period of study intervention
Family members of employees of the Sponsor or the study site.
Use of any prescription medications prior to and/or during the study period for more than or equal to two weeks.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adedotun J Owolabi, MSc
Phone
+23401271500
Ext
2661
Email
adedotun.owolabi@frieslandcampina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Schaafsma, PhD
Phone
+34582992424
Email
anne.schafsma@frieslandcampina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Idowu O Senbanjo, MBBS
Organizational Affiliation
LAGOS STATE UNIVERSITY COLLEGE OF MEDICINE
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35571933
Citation
Senbanjo IO, Owolabi AJ, Oshikoya KA, Hageman JHJ, Adeniyi Y, Samuel F, Melse-Boonstra A, Schaafsma A. Effect of a Fortified Dairy-Based Drink on Micronutrient Status, Growth, and Cognitive Development of Nigerian Toddlers- A Dose-Response Study. Front Nutr. 2022 Apr 27;9:864856. doi: 10.3389/fnut.2022.864856. eCollection 2022.
Results Reference
derived
Learn more about this trial
The Effect of Fortified Growing-up Milk on Growth and Micronutrient Status of Nigerian Toddlers
We'll reach out to this number within 24 hrs