Nutritional Deficiency Clinical Trial
Official title:
The Effect of Fortified Growing-up Milk on Growth and Micronutrient Status of Nigerian Toddlers
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.
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.
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