NCT03783338

Interaction Effects of Vitamin D Supplementation and Aerobic Exercises on Balance and Physical Performance in Children With Down Syndrome

Completed NA Last updated 2 December 2019

What this trial tests

NA trial testing Aerobic exercises and Vitamin D supplementation in Children With Down Syndrome in 59 participants. Completed in 2 March 2019.

Timeline

2 December 2018

Primary endpoint
2 March 2019

2 March 2019

Quick facts

Lead sponsor	Cairo University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	59
Start date	2 December 2018
Primary completion	2 March 2019
Estimated completion	2 March 2019
Sites	1 location across Egypt

Drugs / interventions tested

• Aerobic exercises and Vitamin D supplementation

Conditions studied

• Children With Down Syndrome — all drugs for Children With Down Syndrome →

Sponsor

Cairo University

Who can join

Adults 8 to 12, any sex, with Children With Down Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Objective: To investigate the interaction effects of vitamin D supplementation and aerobic exercises on balance control and physical performance in children with Down syndrome (DS).

Methods: Forty-five children with DS ranging in age from 8 to 12 years will be selected and will participate in this study. They will be assigned randomly using sealed envelopes into three equal groups (A, B and C). Group A will consist of 15 children and will receive the conventional physical therapy program (CPTP) only. Group B will consist of 15 children and will receive the CPTP plus the aerobic exercises. Group C also will consist of 15 children and will receive the CPTP, the aerobic exercises and Vitamin D supplementation in the form of an oral dose of vitamin D3 1000 IU (Cholecalciferol). The program of treatment will be 3 days/week for 12 weeks. Evaluation of balance by using the biodex balance system and physical performance by using the six-minute walk test (6MWT) will be conducted at baseline and after 12 weeks of the treatment program.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.