Nutrigenomics, PUFA, Iron and Cognition Amongst Under-two-year-old Indonesian Children (NUPICO)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Wageningen University
Information provided by (Responsible Party):
Umi Fahmida, Indonesia University
ClinicalTrials.gov Identifier:
NCT01504633
First received: December 31, 2011
Last updated: February 25, 2014
Last verified: February 2014

December 31, 2011
February 25, 2014
December 2011
December 2014   (final data collection date for primary outcome measure)
change in cognitive function (MDI score) [ Time Frame: within 24 weeks after start of intervention ] [ Designated as safety issue: No ]
Mental Developmental Index (MDI) score of Bayley Scale of Infant Development (BSID)
Same as current
Complete list of historical versions of study NCT01504633 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Not Provided
 
Nutrigenomics, PUFA, Iron and Cognition Amongst Under-two-year-old Indonesian Children
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Cognitive Ability, General
Dietary Supplement: DHA/EPA and iron supplementation
24-week supplementation consisting of daily dosage of DHA/EPA or placebo capsule and iron/placebo syrup Capsule: DHA/EPA (100mg DHA + 20mg per day) or placebo Syrup: Fe syrup (16mg elemental iron per day) or placebo
  • Experimental: DHA+EPA Group
    DHA/EPA capsule (100mg DHA + 20mg) and placebo syrup per day
    Intervention: Dietary Supplement: DHA/EPA and iron supplementation
  • Experimental: Fe Group
    Placebo capsule and Fe syrup (16mg elemental iron) per day
    Intervention: Dietary Supplement: DHA/EPA and iron supplementation
  • Experimental: DHA/EPA+Fe Group
    DHA/EPA capsule (100mg DHA + 20mg) and Fe syrup (16mg elemental iron) per day
    Intervention: Dietary Supplement: DHA/EPA and iron supplementation
  • Experimental: Placebo Group
    Placebo capsule and placebo syrup
    Intervention: Dietary Supplement: DHA/EPA and iron supplementation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
240
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Child aged 12 to 17months old
  • Both father and mother of Sasak ethnicity
  • Currently breastfed

Exclusion Criteria:

  • Birth weight <2500 grams (LBW)
  • Congenital malformation and/or disorder that interfered with adequate functioning in daily life
  • Hemoglobin value below 70 g/L
  • Malaria
  • Maternal depression
Both
12 Months to 16 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Indonesia
 
NCT01504633
NUPICO-Indonesia
No
Umi Fahmida, Indonesia University
Indonesia University
Wageningen University
Principal Investigator: Umi Fahmida, PhD SEAMEO Regional Center for Food and Nutrition (RECFON) University of Indonesia
Indonesia University
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP