VitD_SCI: Vitamin D Supplementation in Wheelchair Indoor Athletes

Sponsor

Swiss Paraplegic Centre Nottwil (Other)

Overall Status

Completed

CT.gov ID

NCT02621320

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

There is a high prevalence of vitamin D deficiency in Switzerland. In indoor-athletes as well as wheelchair users, vitamin D deficiency occurs even more often. It is well established that vitamin D deficiency has a negative effect on health. However, vitamin D supplementation in individuals with a vitamin D deficiency has a positive effect on muscle performance. In recently published studies with able-bodied subjects, it has been shown that a normal vitamin D level (>75nmol/L) can only be achieved with a high-dose supplementation of vitamin D.

The aim of this study is to examine the effect of vitamin D supplementation on exercise performance in wheelchair athletes with vitamin D deficiency . All participants with a vitamin D deficiency are assigned to the intervention group and treated with 6000 IU of vitamin D3 daily over a period of 12 weeks. All participants who have a normal vitamin D level will receive placebo treatment (control group). The physical performance is measured three times at baseline, after six weeks and 12 weeks. The measurements include a Wingate and a dynamometer test.

Condition or Disease	Intervention/Treatment	Phase
Vitamin D Deficiency Spinal Cord Injury Drug Effects Dietary Supplements Physical Education and Training/Methods	Dietary Supplement: Vitamin D Dietary Supplement: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Effect of Vitamin D3 Supplementation on Exercise Performance in Wheelchair Athletes.

Study Start Date :

Nov 1, 2015

Actual Primary Completion Date :

Jul 1, 2016

Actual Study Completion Date :

Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vitamin D alcohol-based (Ethanol 65%) Vitamin D3 (Vi-De 3®. WILD) solution 6000IU per day.	Dietary Supplement: Vitamin D Vitamin D3 (Vi-De 3®. WILD) 6000IU daily over a period of 12 weeks.
Placebo Comparator: Placebo Same alcohol-based solution (Ethanol 65%) as intervention product but without cholecalciferol	Dietary Supplement: Placebo alcohol-based solution 1.3ml daily over a period of 12 weeks.

Arm

Intervention/Treatment

Experimental: Vitamin D

alcohol-based (Ethanol 65%) Vitamin D3 (Vi-De 3®. WILD) solution 6000IU per day.

Dietary Supplement: Vitamin D

Vitamin D3 (Vi-De 3®. WILD) 6000IU daily over a period of 12 weeks.

Placebo Comparator: Placebo

Same alcohol-based solution (Ethanol 65%) as intervention product but without cholecalciferol

Dietary Supplement: Placebo

alcohol-based solution 1.3ml daily over a period of 12 weeks.

Outcome Measures

Primary Outcome Measures

peak power [delta change from pre to 12 weeks post supplementation]
peak power measured during wingate test
maximum torque [delta change from pre to 12 weeks post supplementation]
maximum torque measured with dynamometer

Secondary Outcome Measures

Vitamin D serum level [week 0, 1 day before they start supplementation]
measured with venous blood sample
Vitamin D serum level [12 weeks post supplementation]
measured with venous blood sample
Count of injuries [12 weeks post supplementation]
DASH questionaire

Other Outcome Measures

Heart rate [week 0, 1 day before they start supplementation]
Peak heart rate measured during wingate test
Heart rate [12 weeks post supplementation]
Peak heart rate measured during wingate test
blood lactate concentration [week 0, 1 day before they start supplementation]
before, during and after wingate test
blood lactate concentration [12 weeks post supplementation]
before, during and after wingate test