Effect of DHA Supplementation on Cognitive Performance and Growth in Chinese Children

Not Applicable

• Conditions: Healthy
• Interventions: Dietary Supplement: Vitamins + DHA supplement (Vitamins A,D, E and algal oil); Dietary Supplement: Vitamins supplement (Vitamins A,D, E and corn oil)

• Registration Number: NCT02308930
• Lead Sponsor: Sun Yat-sen University

Brief Summary

The purpose of this study is to determine whether DHA supplement (in a daily dose of 300 mg) will improve the cognitive performance, associated metabolism and growth in normal children aged 6-12 years in primary schools.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-11-30
• Status Verified: 2014-12
• Study First Submitted QC: 2014-12-04
• Last Update Submitted: 2014-12-04
• Study First Posted: 2014-12-05
• Last Update Posted: 2014-12-05
• Primary Completion: 2015-05
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

1. Children aged 6-12 years from primary schools.
2. Healthy as assessed by a physician.
3. Willing to participate in the study, consume the test product and perform all measurements including cognitive testing, blood drawing, urine samples, anthropometry and questionnaires.
4. Willing to maintain current dietary habits and intend to stay in the study area for ≥ one year.
5. Informed consent signed by parent or caregiver and oral consent given by child.

Exclusion Criteria

1. Children with obvious mental and physical handicaps.
2. Children taking medication which interferes with study measurements (e.g., psychoactive medications or medications expected to affect behavior and learning).
3. Taking dietary supplements already.
4. Suffering major life events (immediate family death, parents divorce, etc.) within six months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamins + DHA supplement	Vitamins + DHA supplement (Vitamins A,D, E and algal oil)	2 x 400 mg capsules per day orally for 6 months, each capsule providing 154μg Vitamin A, 2.36μg Vitamin D, 0.4mg Vitamin E and 375mg algal oil (containing 150mg DHA).
Vitamins supplement	Vitamins supplement (Vitamins A,D, E and corn oil)	2 x 400 mg capsules per day orally for 6 months, each capsule providing 154μg Vitamin A, 2.36μg Vitamin D, 0.4mg Vitamin E and 375mg corn oil (free of omega-3 fatty acids).

Primary Outcome Measures

Name	Time	Method
Performance on Wisconsin card sorting test (WCST) and digit span test	6 months	At baseline, 3 and 6 months cognitive tests will be administered, and the scores of Wisconsin card sorting test (WCST) and digit span test will be recorded.

Secondary Outcome Measures

Name	Time	Method
DHA related metabolites and neurotransmitters (blood concentration of DHA related metabolites and neurotransmitters)	6 months	At baseline and 6 months, blood samples will be drawn and the concentration of DHA related metabolites and neurotransmitters will be detected using biochemical methods.