The Effect of Fortified Growing-up Milk on Growth and Micronutrient Status of Nigerian Toddlers
GaGA
1 other identifier
interventional
150
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2018
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2017
CompletedFirst Posted
Study publicly available on registry
January 26, 2018
CompletedStudy Start
First participant enrolled
February 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 8, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 24, 2019
CompletedJanuary 29, 2018
January 1, 2018
7 months
December 11, 2017
January 26, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Iron deficiency anaemia
Prevalence of Iron deficiency anaemia as assessed by haemoglobin concentration
6 Months
Secondary Outcomes (9)
Hematocrit
6 months
Ferritin
6 months
plasma concentrations of specific inflammation markers (i.e. C-Reactive)
6 months
Weight
6 months
Serum concentrations of specific micronutrient status
6 Months
- +4 more secondary outcomes
Other Outcomes (1)
intestinal microbiome
6 months
Study Arms (3)
200ml
OTHERToddlers will be allocated to the 200 ml group
400ml
OTHERToddlers will be allocated to the 400 ml group
600ml
OTHERToddlers will be allocated to the 600 ml
Interventions
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- FrieslandCampina WAMCO Nigeria PLClead
- Lagos State Universitycollaborator
Related Publications (1)
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.
PMID: 35571933DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Idowu O Senbanjo, MBBS
LAGOS STATE UNIVERSITY COLLEGE OF MEDICINE
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2017
First Posted
January 26, 2018
Study Start
February 5, 2018
Primary Completion
September 8, 2018
Study Completion
January 24, 2019
Last Updated
January 29, 2018
Record last verified: 2018-01