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

Children Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02426554
• Other study ID #: Braindrop
• Status: Completed
• Phase: N/A
• First received: April 16, 2015
• Last updated: August 2, 2016
• Start date: January 2011
• Est. completion date: June 2011

Study information

• Verified date: August 2016
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 11 Years

Eligibility

Inclusion Criteria:

• age 8 to 11 yrs.

Exclusion Criteria:

• history of neurological or psychiatric disorders.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Children

Intervention

Dietary Supplement:
• DDU-supplement
DDU: Vitamin D, DHA, Uridine
• Placebo supplement

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Copenhagen	Helene Elsass Center, Denmark., Technical University of Denmark

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance to cognitive and motor training program (Move It To Improve It: MiTii)	Internet based program with evaluation of numbers of training sessions. At least 14 training sessions out of 18 should be completed.	6 weeks	No
Primary	Dietary compliance	Supplement was provided to the children and ingestion was registered by the parents.	6 weeks	No