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The Effect of Fortified Growing-up Milk on Growth and Micronutrient Status of Nigerian Toddlers

NCT03411590 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2018-01-29

No results posted yet for this study

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.

Conditions

  • Malnutrition; Mild
  • Iron-deficiency Anemia
  • Nutritional Stunting
  • Nutritional Wasting
  • Nutritional Deficiency
  • Enterobacteriaceae Infections

Interventions

OTHER

Fortified milk Powder

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)

Sponsors & Collaborators

  • Lagos State University

    collaborator OTHER

  • FrieslandCampina WAMCO Nigeria PLC

    lead INDUSTRY

Principal Investigators

  • Idowu O Senbanjo, MBBS · LAGOS STATE UNIVERSITY COLLEGE OF MEDICINE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
3 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-05
Primary Completion
2018-09-08
Completion
2019-01-24

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03411590 on ClinicalTrials.gov