NCT02308930

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
106

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable healthy

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 5, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

December 5, 2014

Status Verified

December 1, 2014

Enrollment Period

10 months

First QC Date

November 30, 2014

Last Update Submit

December 4, 2014

Conditions

Healthy

Outcome Measures

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.

    6 months

Secondary Outcomes (1)

  • DHA related metabolites and neurotransmitters (blood concentration of DHA related metabolites and neurotransmitters)

    6 months

Study Arms (2)

Vitamins + DHA supplement

EXPERIMENTAL

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)

Vitamins supplement

OTHER

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

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

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 32979077DERIVED

MeSH Terms

Interventions

VitaminsCorn Oil

Intervention Hierarchy (Ancestors)

MicronutrientsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesNutrientsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesDietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsPlant PreparationsBiological ProductsComplex Mixtures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 30, 2014

First Posted

December 5, 2014

Study Start

July 1, 2014

Primary Completion

May 1, 2015

Study Completion

October 1, 2015

Last Updated

December 5, 2014

Record last verified: 2014-12