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

NCT ID: NCT02308930

Last Updated: 2014-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-10-31

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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamins + DHA supplement

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).

Group Type EXPERIMENTAL

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

Intervention Type DIETARY_SUPPLEMENT

Vitamins supplement

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).

Group Type OTHER

Vitamins supplement (Vitamins A,D, E and corn oil)

Intervention Type DIETARY_SUPPLEMENT

Interventions

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

Intervention Type DIETARY_SUPPLEMENT

Vitamins supplement (Vitamins A,D, E and corn oil)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Huilian Zhu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Yang GY, Wu T, Huang SY, Huang BX, Wang HL, Lan QY, Li CL, Zhu HL, Fang AP. No effect of 6-month supplementation with 300 mg/d docosahexaenoic acid on executive functions among healthy school-aged children: a randomized, double-blind, placebo-controlled trial. Eur J Nutr. 2021 Jun;60(4):1985-1997. doi: 10.1007/s00394-020-02388-w. Epub 2020 Sep 26.

Reference Type DERIVED
PMID: 32979077 (View on PubMed)

Other Identifiers

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TY0131002

Identifier Type: -

Identifier Source: org_study_id