Cognitive Ability, General Clinical Trial
Official title:
Can NUtrigenomics / Nutrigenetics Help Explain the Mixed Results on Effect of LCPUFA (DHA) and Iron on Child COgnition?
Rationale: Review on the positive effect of long chain polyunsaturated fatty acids (LCPUFA),
especially docosahexanoic acid (DHA), supplementation on cognitive function in human using
randomized controlled trials (RCTs) showed that results in RCTs were mixed and inconsistent.
It has been suggested that the effect may be subtle, which is currently difficult to detect,
but could be significant, or there may be individual variation which mediate the effect.
Objectives: This study aims to assess gene-nutrient inter-relation in explaining the effect
of LCPUFAs i.e. DHA and/or iron on cognitive functioning of children <24mo in Indonesia.
Specifically the study's objectives are: (1) to assess effect of LCPUFA (as DHA oil) and
iron (as iron supplement) in altering gene expressions, and (2) to assess the mediating
effect of genes involved in fatty acid and iron metabolism in improving serum LCPUFA,
alpha-linolenic acids (ALA), DHA and cognitive function.
Study design and study population: The study is a double-blind randomized controlled trial
with children aged less than 24 months (window of opportunity). The study area is in East
Lombok district, in West Nusa Tenggara province, Indonesia where nutrient intake including
iron and presumably LCPUFA, is not optimal.
Intervention: The study is an intervention study, consisting of four groups: DHA, iron,
DHA+iron, and placebo (60 subjects/group = 240 subjects in total). Capsule containing
100mg/d DHA or its placebo and syrup containing 16mg/d iron will be given daily for 24
weeks. Before and after the intervention child cognition (as Bayley Mental Developmental
Index or MDI score), serum PUFA level, iron status (haemoglobin, transferrin receptor,
ferritin), inflammation status (CRP, AGP), gene expression profiles, and potential
confounders of child cognition such as lengt-for-age, weight-for-length, and weight-for-age
Z-scores, stimulation/home environment, maternal characteristics will be collected.
Study outcome: The primary study outcomes will be cognitive score (as Bayley Mental
Developmental Index or MDI score) and gene expression profiles. Secondary study outcomes
will be serum PUFA level, iron status (haemoglobin, TfR, ferritin).
Nature and extent of the burden and risks benefit and group relatedness:
Subjects, who will be included into the study will invest 14 hours. The consumption of iron
is not associated with any increased risk of iron overload both for infectious (including
malaria) and chronic diseases nor consumption of n-3 fatty acids EPA and DHA exceed the US
Food and Drug Administrator (FDA) Generally Recognized as Save (GRAS) limit. Venous blood of
5 mL will be drawn at baseline and endline. During screening, children with severe anaemia
(Hb<70g/L) will be excluded from the study and referred to the local public health center
for further treatment.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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