Dietary Supplementation of of DHA, Vitamin D3 and Uridine in Children

August 2, 2016 updated by: Solvejg Hansen, University of Copenhagen
The feasibility of combining a motor and cognitive exercise program with dietary supplementation (DDU: Vitamin D, DHA and Uridine or Placebo) is tested in a smaller group of prepubescent children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 11 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

- age 8 to 11 yrs.

Exclusion Criteria:

  • history of neurological or psychiatric disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
Dietary supplement: DDU-supplement
DDU: Vitamin D, DHA, Uridine
Placebo Comparator: Group 2
Dietary supplement: Placebo supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance to cognitive and motor training program (Move It To Improve It: MiTii)
Time Frame: 6 weeks
Internet based program with evaluation of numbers of training sessions. At least 14 training sessions out of 18 should be completed.
6 weeks
Dietary compliance
Time Frame: 6 weeks
Supplement was provided to the children and ingestion was registered by the parents.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

Technical University of Denmark
Helene Elsass Center, Denmark.

Investigators

  • Study Director: Jens Bo Nielsen, Professor, NEXS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

April 16, 2015

First Submitted That Met QC Criteria

April 21, 2015

First Posted (Estimate)

April 27, 2015

Study Record Updates

Last Update Posted (Estimate)

August 3, 2016

Last Update Submitted That Met QC Criteria

August 2, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • Braindrop

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

3
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