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Vitamin D Supplementation in Wheelchair Indoor Athletes (VitD_SCI)

Primary Purpose

Vitamin D Deficiency, Spinal Cord Injury, Drug Effects

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Vitamin D
Placebo
Sponsored by
Swiss Paraplegic Research, Nottwil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin D Deficiency focused on measuring Vitamin D, Exercise Performance, Wheelchair Athletes, Indoor sports, Wingate, Isokinetic Dynamometer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Swiss Paraplegic Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin D

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

peak power
peak power measured during wingate test
maximum torque
maximum torque measured with dynamometer

Secondary Outcome Measures

Vitamin D serum level
measured with venous blood sample
Vitamin D serum level
measured with venous blood sample
Count of injuries
DASH questionaire

Full Information

First Posted
November 24, 2015
Last Updated
November 21, 2016
Sponsor
Swiss Paraplegic Research, Nottwil
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1. Study Identification

Unique Protocol Identification Number
NCT02621320
Brief Title
Vitamin D Supplementation in Wheelchair Indoor Athletes
Acronym
VitD_SCI
Official Title
Effect of Vitamin D3 Supplementation on Exercise Performance in Wheelchair Athletes.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Paraplegic Research, Nottwil

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency, Spinal Cord Injury, Drug Effects, Dietary Supplements, Physical Education and Training/Methods
Keywords
Vitamin D, Exercise Performance, Wheelchair Athletes, Indoor sports, Wingate, Isokinetic Dynamometer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D
Arm Type
Experimental
Arm Description
alcohol-based (Ethanol 65%) Vitamin D3 (Vi-De 3®. WILD) solution 6000IU per day.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Same alcohol-based solution (Ethanol 65%) as intervention product but without cholecalciferol
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Intervention Description
Vitamin D3 (Vi-De 3®. WILD) 6000IU daily over a period of 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
alcohol-based solution 1.3ml daily over a period of 12 weeks.
Primary Outcome Measure Information:
Title
peak power
Description
peak power measured during wingate test
Time Frame
delta change from pre to 12 weeks post supplementation
Title
maximum torque
Description
maximum torque measured with dynamometer
Time Frame
delta change from pre to 12 weeks post supplementation
Secondary Outcome Measure Information:
Title
Vitamin D serum level
Description
measured with venous blood sample
Time Frame
week 0, 1 day before they start supplementation
Title
Vitamin D serum level
Description
measured with venous blood sample
Time Frame
12 weeks post supplementation
Title
Count of injuries
Description
DASH questionaire
Time Frame
12 weeks post supplementation
Other Pre-specified Outcome Measures:
Title
Heart rate
Description
Peak heart rate measured during wingate test
Time Frame
week 0, 1 day before they start supplementation
Title
Heart rate
Description
Peak heart rate measured during wingate test
Time Frame
12 weeks post supplementation
Title
blood lactate concentration
Description
before, during and after wingate test
Time Frame
week 0, 1 day before they start supplementation
Title
blood lactate concentration
Description
before, during and after wingate test
Time Frame
12 weeks post supplementation

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Swiss Paraplegic Centre
City
Nottwil
State/Province
Lucerne
ZIP/Postal Code
6207
Country
Switzerland

12. IPD Sharing Statement

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Vitamin D Supplementation in Wheelchair Indoor Athletes

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