HealthyNCT02308930
Effect of DHA Supplementation on Cognitive Performance and Growth in Chinese Children
A study testing Vitamins + DHA supplement (Vitamins A,D, E and algal oil) and Vitamins supplement (Vitamins A,D, E and corn oil) in people with Healthy, run by Sun Yat-sen University.
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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Healthy
- What is being tested?
- Vitamins + DHA supplement (Vitamins A,D, E and algal oil) and Vitamins supplement (Vitamins A,D, E and corn oil)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Effect of Dietary DHA Supplementation on Cognitive Performance and Growth in Chinese School Children: A Randomized Controlled Study
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.
- Conditions
- Healthy
- Being tested
- Vitamins + DHA supplement (Vitamins A,D, E and algal oil), Vitamins supplement (Vitamins A,D, E and corn oil)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamins + DHA supplement (Vitamins A,D, E and algal oil)Dietary supplement
Vitamins supplement (Vitamins A,D, E and corn oil)Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Dietary Supplement: Vitamins supplement (Vitamins A,D, E and corn oil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startJul 2014
- Primary completionMay 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huilian Zhu, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02308930
- Sponsor's protocol ID
- TY0131002
- Status last verified
- Dec 2014
- First submitted
- 30 Nov 2014
- Last updated
- 5 Dec 2014
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dietary DHA Supplementation on Cognitive Performance and Growth in Chinese School Children: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02308930
- Acronym / sponsor ID
- TY0131002
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- May 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 5 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamins + DHA supplement | Experimental | Dietary Supplement: Vitamins + DHA supplement (Vitamins A,D, E and algal oil)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). |
| Vitamins supplement | Other | Dietary Supplement: Vitamins supplement (Vitamins A,D, E and corn oil)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). |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
Performance on Wisconsin card sorting test (WCST) and digit span test
Time frame: 6 months
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.
1 secondary outcome
DHA related metabolites and neurotransmitters (blood concentration of DHA related metabolites and neurotransmitters)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2014.
- Derived from this study: PubMed 32979077Yang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamins + DHA supplement (Vitamins A,D, E and algal oil) and Vitamins supplement (Vitamins A,D, E and corn oil) in people with Healthy, run by Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance on Wisconsin card sorting test (WCST) and digit span test (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02308930, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2014.