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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02308930
• Other study ID #: TY0131002
• Status: Active, not recruiting
• Phase: N/A
• First received: November 30, 2014
• Last updated: December 4, 2014
• Start date: July 2014
• Est. completion date: October 2015

Study information

• Verified date: December 2014
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 106
• Est. completion date: October 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

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

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No