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Status unknownNCT02308930Updated Dec 5, 2014

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

An interventional study of Vitamins + DHA supplement (Vitamins A,D, E and algal oil) and Vitamins supplement (Vitamins A,D, E and corn oil) in Healthy, sponsored by Sun Yat-sen University. Status unknown. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2014-12-05.

Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Dec 2014), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
106
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
106 participants (actual)

Study arms

  • Experimental
    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).

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

  • Other
    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).

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

Interventions

  • Dietary supplementVitamins + DHA supplement (Vitamins A,D, E and algal oil)
  • Dietary supplementVitamins supplement (Vitamins A,D, E and corn oil)
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

Secondary outcomes

  1. 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.

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 32979077 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02308930
Lead sponsor
Sun Yat-sen University
Responsible party
Huilian Zhu (Professor, Sun Yat-sen University) — Principal investigator
First posted
Dec 5, 2014
Start date
Jul 2014
Primary completion
May 2015 (estimated)
Completion
Oct 2015 (estimated)
Last update
Dec 5, 2014
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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