Vitamin D Supplementation in Wheelchair Indoor Athletes (VitD_SCI)

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

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency; Spinal Cord Injury; Dietary Supplements; Drug Effects; Physical Education and Training/Methods
• Intervention / Treatment: Dietary supplement: Vitamin D; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Lucerne
    • Nottwil, Lucerne, Switzerland, 6207
      • Swiss Paraplegic Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
peak power	peak power measured during wingate test	delta change from pre to 12 weeks post supplementation
maximum torque	maximum torque measured with dynamometer	delta change from pre to 12 weeks post supplementation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vitamin D serum level	measured with venous blood sample	week 0, 1 day before they start supplementation
Vitamin D serum level	measured with venous blood sample	12 weeks post supplementation
Count of injuries	DASH questionaire	12 weeks post supplementation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Peak heart rate measured during wingate test	week 0, 1 day before they start supplementation
Heart rate	Peak heart rate measured during wingate test	12 weeks post supplementation
blood lactate concentration	before, during and after wingate test	week 0, 1 day before they start supplementation
blood lactate concentration	before, during and after wingate test	12 weeks post supplementation

Collaborators and Investigators

• Sponsor: Swiss Paraplegic Centre Nottwil

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: November 24, 2015
• First Submitted That Met QC Criteria: December 1, 2015
• First Posted (Estimate): December 3, 2015

Study Record Updates

• Last Update Posted (Estimate): November 22, 2016
• Last Update Submitted That Met QC Criteria: November 21, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Vitamin D; Wingate; Exercise Performance; Wheelchair Athletes; Indoor sports; Isokinetic Dynamometer
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Nutrition Disorders; Trauma, Nervous System; Spinal Cord Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Spinal Cord Injuries; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: 2015-11