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Vitamin D Supplementation in Wheelchair Indoor Athletes

NCT ID: NCT02621320

Last Updated: 2016-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Keywords

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Vitamin D Exercise Performance Wheelchair Athletes Indoor sports Wingate Isokinetic Dynamometer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Vitamin D

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

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Vitamin D

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Swiss Paraplegic Research, Nottwil

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2015-11

Identifier Type: -

Identifier Source: org_study_id