NCT02426554

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

Shorter than P25 for not_applicable

Status
completed

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

January 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 27, 2015

Completed
Last Updated

August 3, 2016

Status Verified

August 1, 2016

Enrollment Period

5 months

First QC Date

April 16, 2015

Last Update Submit

August 2, 2016

Conditions

Children

Outcome Measures

Primary Outcomes (2)

  • 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

  • Dietary compliance

    Supplement was provided to the children and ingestion was registered by the parents.

    6 weeks

Study Arms (2)

Group 1

ACTIVE COMPARATOR
Dietary Supplement: DDU-supplement

Group 2

PLACEBO COMPARATOR
Dietary Supplement: Placebo supplement

Interventions

DDU-supplementDIETARY_SUPPLEMENT

DDU: Vitamin D, DHA, Uridine

Group 1
Placebo supplementDIETARY_SUPPLEMENT
Group 2

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • \- age 8 to 11 yrs.

You may not qualify if:

  • history of neurological or psychiatric disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hansen SL, Ritterband-Rosenbaum A, Voigt CB, Hellgren LI, Sorensen AM, Jacobsen C, Greve LZ, Jorgensen KD, Bilde PE, Kiens B, Nielsen JB. Supplementation of docosahexaenoic acid (DHA), vitamin D3 and uridine in combination with six weeks of cognitive and motor training in prepubescent children: a pilot study. BMC Nutr. 2017 Apr 17;3:37. doi: 10.1186/s40795-017-0155-1. eCollection 2017.

    PMID: 32153817DERIVED

Study Officials

  • Jens Bo Nielsen, Professor

    NEXS

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cand Scient Human Physiology

Study Record Dates

First Submitted

April 16, 2015

First Posted

April 27, 2015

Study Start

January 1, 2011

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

August 3, 2016

Record last verified: 2016-08