Vitamin D Supplementation in Wheelchair Indoor Athletes

Vitamin D Deficiency Clinical Trial

— VitD_SCI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02621320
• Other study ID #: 2015-11
• Status: Completed
• Phase: N/A
• First received: November 24, 2015
• Last updated: November 21, 2016
• Start date: November 2015
• Est. completion date: August 2016

Study information

• Verified date: November 2016
• Source: Swiss Paraplegic Centre Nottwil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• swiss elite wheelchair athlete

• 18 to 60 years

• male, healthy

• at least 2x45min sports a week

Exclusion Criteria:

• participation in another study

• medication which influences performance

• respiratory and cardiovascular disease

• daily intake of >400IU Vitamin D

• parathyroid gland disease

• kidney insufficiency

• visit abroad below the 37th parallel latitude during study or shortly before

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dietary Supplements
• Drug Effects
• Physical Education and Training/Methods
• Spinal Cord Injuries
• Spinal Cord Injury
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Vitamin D
Vitamin D3 (Vi-De 3®. WILD) 6000IU daily over a period of 12 weeks.
• Placebo
alcohol-based solution 1.3ml daily over a period of 12 weeks.

Locations

Country	Name	City	State
Switzerland	Swiss Paraplegic Centre	Nottwil	Lucerne

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Paraplegic Centre Nottwil

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Heart rate	Peak heart rate measured during wingate test	week 0, 1 day before they start supplementation	No
Other	Heart rate	Peak heart rate measured during wingate test	12 weeks post supplementation	No
Other	blood lactate concentration	before, during and after wingate test	week 0, 1 day before they start supplementation	No
Other	blood lactate concentration	before, during and after wingate test	12 weeks post supplementation	No
Primary	peak power	peak power measured during wingate test	delta change from pre to 12 weeks post supplementation	No
Primary	maximum torque	maximum torque measured with dynamometer	delta change from pre to 12 weeks post supplementation	No
Secondary	Vitamin D serum level	measured with venous blood sample	week 0, 1 day before they start supplementation	Yes
Secondary	Vitamin D serum level	measured with venous blood sample	12 weeks post supplementation	Yes
Secondary	Count of injuries	DASH questionaire	12 weeks post supplementation	No