NCT02621320

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 3, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

November 22, 2016

Status Verified

November 1, 2016

Enrollment Period

8 months

First QC Date

November 24, 2015

Last Update Submit

November 21, 2016

Conditions

Vitamin D DeficiencySpinal Cord InjuryDrug EffectsDietary SupplementsPhysical Education and Training/Methods

Keywords

Vitamin DExercise PerformanceWheelchair AthletesIndoor sportsWingateIsokinetic Dynamometer

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Vitamin D serum level

    week 0, 1 day before they start supplementation

  • Vitamin D serum level

    12 weeks post supplementation

  • Count of injuries

    12 weeks post supplementation

Other Outcomes (4)

  • Heart rate

    week 0, 1 day before they start supplementation

  • Heart rate

    12 weeks post supplementation

  • blood lactate concentration

    week 0, 1 day before they start supplementation

  • +1 more other outcomes

Study Arms (2)

Vitamin D

EXPERIMENTAL

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

Dietary Supplement: Vitamin D

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Vitamin DDIETARY_SUPPLEMENT

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

Vitamin D
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • swiss elite wheelchair athlete
  • to 60 years
  • male, healthy
  • at least 2x45min sports a week

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

MeSH Terms

Conditions

Vitamin D DeficiencySpinal Cord Injuries

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesSpinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2015

First Posted

December 3, 2015

Study Start

November 1, 2015

Primary Completion

July 1, 2016

Study Completion

August 1, 2016

Last Updated

November 22, 2016

Record last verified: 2016-11

Locations

CH(1)