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

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Dietary DHA Supplementation on Cognitive Performance and Growth in Chinese School Children: A Randomized Controlled Study

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Vitamins + DHA supplement (Vitamins A,D, E and algal oil)
* Dietary Supplement: Vitamins supplement (Vitamins A,D, E and corn oil)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged 6-12 years from primary schools. Healthy as assessed by a physician. Willing to participate in the study, consume the test product and perform all measurements including cognitive testing, blood drawing, urine samples, anthropometry and questionnaires. Willing to maintain current dietary habits and intend to stay in the study area for ≥ one year. Informed consent signed by parent or caregiver and oral consent given by child. Exclusion Criteria: Children with obvious mental and physical handicaps. Children taking medication which interferes with study measurements (e.g., psychoactive medications or medications expected to affect behavior and learning). Taking dietary supplements already. Suffering major life events (immediate family death, parents divorce, etc.) within six months.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamins + DHA supplement<br>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). | Dietary Supplement: Vitamins + DHA supplement (Vitamins A,D, E and algal oil)<br> <br> |
| Other: Vitamins supplement<br>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). | Dietary Supplement: Vitamins supplement (Vitamins A,D, E and corn oil)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance on Wisconsin card sorting test (WCST) and digit span test | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DHA related metabolites and neurotransmitters (blood concentration of DHA related metabolites and neurotransmitters) | 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. | 6 months |