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Completed

NCT Number: NCT02621320

Vitamin D Supplementation in Wheelchair Indoor 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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

  1. peak power

    Time frame: delta change from pre to 12 weeks post supplementation

    peak power measured during wingate test

  2. maximum torque

    Time frame: delta change from pre to 12 weeks post supplementation

    maximum torque measured with dynamometer

Secondary outcomes

  1. Vitamin D serum level

    Time frame: week 0, 1 day before they start supplementation

    measured with venous blood sample

  2. Vitamin D serum level

    Time frame: 12 weeks post supplementation

    measured with venous blood sample

  3. Count of injuries

    Time frame: 12 weeks post supplementation

    DASH questionaire

Other outcomes

  1. Heart rate

    Time frame: week 0, 1 day before they start supplementation

    Peak heart rate measured during wingate test

  2. Heart rate

    Time frame: 12 weeks post supplementation

    Peak heart rate measured during wingate test

  3. blood lactate concentration

    Time frame: week 0, 1 day before they start supplementation

    before, during and after wingate test

  4. blood lactate concentration

    Time frame: 12 weeks post supplementation

    before, during and after wingate test

Sponsors and collaborators

Lead sponsor

Swiss Paraplegic Research, Nottwil

Network

Registry information

Official study title

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

Acronym: VitD_SCI

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 3, 2015
Registry last updated
Nov 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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