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Vitamin D Supplementation in Wheelchair Indoor Athletes (VitD_SCI)

S

Swiss Paraplegic Research, Nottwil

Status

Completed

Conditions

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

Treatments

Dietary Supplement: Vitamin D
Dietary Supplement: Placebo

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT02621320
2015-11

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

20 participants in 2 patient groups, including a placebo group

Vitamin D
Experimental group
Description:
alcohol-based (Ethanol 65%) Vitamin D3 (Vi-De 3®. WILD) solution 6000IU per day.
Treatment:
Dietary Supplement: Vitamin D
Placebo
Placebo Comparator group
Description:
Same alcohol-based solution (Ethanol 65%) as intervention product but without cholecalciferol
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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