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
  Purpose

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.


Condition Intervention
Cognitive Ability, General
Dietary Supplement: DHA/EPA and iron supplementation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Can NUtrigenomics / Nutrigenetics Help Explain the Mixed Results on Effect of LCPUFA (DHA) and Iron on Child COgnition?

Resource links provided by NLM:


Further study details as provided by Indonesia University:

Primary Outcome Measures:
  • 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)


Estimated Enrollment: 240
Study Start Date: December 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DHA+EPA Group
DHA/EPA capsule (100mg DHA + 20mg) and placebo syrup per day
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: Fe Group
Placebo capsule and Fe syrup (16mg elemental iron) per day
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+Fe Group
DHA/EPA capsule (100mg DHA + 20mg) and Fe syrup (16mg elemental iron) per day
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: Placebo Group
Placebo capsule and placebo syrup
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

  Eligibility

Ages Eligible for Study:   12 Months to 16 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01504633

Locations
Indonesia
SEAMEO Regional Center for Food and Nutrition (RECFON) University of Indonesia
Jakarta, DKI Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University
Wageningen University
Investigators
Principal Investigator: Umi Fahmida, PhD SEAMEO Regional Center for Food and Nutrition (RECFON) University of Indonesia
  More Information

Additional Information:
Publications:

Responsible Party: Umi Fahmida, Principal Investigator, Indonesia University
ClinicalTrials.gov Identifier: NCT01504633     History of Changes
Other Study ID Numbers: NUPICO-Indonesia
Study First Received: December 31, 2011
Last Updated: February 25, 2014
Health Authority: Indonesia: Departement Kesehatan (Department of Health)

Keywords provided by Indonesia University:
cognitive function
omega-3 PUFA (DHA)
iron
nutrigenomics
under-two year old children
Indonesia

Additional relevant MeSH terms:
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014