Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)


Related Conditions & MeSH terms


NCT number NCT01504633
Study type Interventional
Source Indonesia University
Contact
Status Active, not recruiting
Phase N/A
Start date December 2011
Completion date December 2014

See also
  Status Clinical Trial Phase
Active, not recruiting NCT00747396 - The Bucharest Early Intervention Project N/A
Completed NCT01407770 - Genetic Susceptibility to Radiation-Induced Skin Reactions in Racial/Ethnic Groups of Patients With Breast Cancer
Completed NCT02394899 - Improving Parental Psychosocial Functioning and Early Developmental Outcomes in Children With Sickle Cell Disease N/A
Completed NCT02274883 - The Effect of Feeding Infant Formula With Enriched Protein Fractions N/A
Enrolling by invitation NCT02066571 - Study to Assess the Clinical Benefit and Safety of Droxidopa in Parkinson's Disease Phase 2
Completed NCT02780739 - INSIGHT, A Comprehensive, Multidisciplinary Brain Training System N/A
Completed NCT01359215 - Childhood Anesthesia and Cognitive Function N/A
Completed NCT02461693 - Evaluating the Role of Expectations in Response to Caffeine Consumption: An RCT N/A
Completed NCT01868165 - Assessing the Impact of Calcium Channel Blockers on COGnitive Function in the Very Elderly (AI-COG)
Completed NCT02630667 - The Acute Effects Fortified Nutritional Supplementation on Childhood Cognition N/A
Completed NCT01375348 - Relationship Between Cognitive Function and Pain Phase 3
Completed NCT02853279 - Physical Activity and Intermittent Exercise Training for Cardiovascular and Cognitive Gain in Obese Women N/A
Completed NCT00894205 - Neuropsychological Effects of Strengthening Exercise for Older Adults Phase 2
Completed NCT04442477 - Neurodevelopment at 5.5 Years of Age in Children Who Received Infant Formula With Enriched Protein Fractions
Completed NCT01167400 - Cybercycling for Cognitive Health N/A
Completed NCT03137836 - Classroom Standing Desks for Reducing Sitting Time in Children N/A
Completed NCT02136368 - Body and Brain Exercise for Older Adults With Memory Complaints N/A
Completed NCT00841321 - Trial of Ginkgo as a Treatment for Cognitive Problems in Multiple Sclerosis Phase 2
Completed NCT02726906 - Lifestyle Enriching Activities for Research in Neuroscience Intervention Trial: LEARNit Study N/A
Not yet recruiting NCT02123355 - The Effect of Dexmedetomidine to Cognition of Geriatrics in Prolonged Surgery Phase 4