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

Sun Yat-sen University

Status: Unknown

Conditions: Healthy

Treatments: Dietary Supplement: Vitamins supplement (Vitamins A,D, E and corn oil); Dietary Supplement: Vitamins + DHA supplement (Vitamins A,D, E and algal oil)

Study type: Interventional

Funder types: Other

Identifiers

NCT02308930

TY0131002

Details and patient eligibility

About

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.

Enrollment: 106 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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106 participants in 2 patient groups

Vitamins + DHA supplement

Experimental group

Description:

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).

Treatment:

Dietary Supplement: Vitamins + DHA supplement (Vitamins A,D, E and algal oil)

Vitamins supplement

Other group

Description:

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).

Treatment:

Dietary Supplement: Vitamins supplement (Vitamins A,D, E and corn oil)