Vitamin D DeficiencyVitD_SCINCT02621320
Vitamin D Supplementation in Wheelchair Indoor Athletes
A study testing Vitamin D in people with Vitamin D Deficiency and Spinal Cord Injury, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Spinal Cord Injury, Drug Effects
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2015to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- swiss elite wheelchair athlete
- 18 to 60 years
- male, healthy
- at least 2x45min sports a week
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, 6207
About this study
Official title: Effect of Vitamin D3 Supplementation on Exercise Performance in Wheelchair 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.
- Conditions
- Vitamin D Deficiency, Spinal Cord Injury, Drug Effects, Dietary Supplements, Physical Education and Training/Methods
- Being tested
- Vitamin D, Placebo
- Keywords
- Vitamin D, Exercise Performance, Wheelchair Athletes, Indoor sports, Wingate, Isokinetic Dynamometer
- Medical subject headings
- Vitamin D Deficiency, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
Vitamin D3 (Vi-De 3®. WILD) 6000IU daily over a period of 12 weeks.
PlaceboDietary supplement
alcohol-based solution 1.3ml daily over a period of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Experimental | alcohol-based (Ethanol 65%) Vitamin D3 (Vi-De 3®. WILD) solution 6000IU per day. Receives: Dietary Supplement: Vitamin D |
| Placebo | Placebo comparator | Same alcohol-based solution (Ethanol 65%) as intervention product but without cholecalciferol Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
peak power
peak power measured during wingate test
Measured: delta change from pre to 12 weeks post supplementation
maximum torque
maximum torque measured with dynamometer
Measured: delta change from pre to 12 weeks post supplementation
Secondary outcomes (3)
Vitamin D serum level
measured with venous blood sample
Measured: week 0, 1 day before they start supplementation
Vitamin D serum level
measured with venous blood sample
Measured: 12 weeks post supplementation
Count of injuries
DASH questionaire
Measured: 12 weeks post supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionJul 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02621320
- Sponsor's protocol ID
- 2015-11
- Acronym
- VitD_SCI
- Status last verified
- Nov 2016
- First submitted
- 24 Nov 2015
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D3 Supplementation on Exercise Performance in Wheelchair Athletes.
- ClinicalTrials.gov ID
- NCT02621320
- Acronym / sponsor ID
- VitD_SCI / 2015-11
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- Nov 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 3 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Experimental | Dietary Supplement: Vitamin Dalcohol-based (Ethanol 65%) Vitamin D3 (Vi-De 3®. WILD) solution 6000IU per day. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSame alcohol-based solution (Ethanol 65%) as intervention product but without cholecalciferol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- swiss elite wheelchair athlete
- 18 to 60 years
- male, healthy
- at least 2x45min sports a week
Key exclusion criteria (7 listed)
- participation in another study
- medication which influences performance
- respiratory and cardiovascular disease
- daily intake of >400IU Vitamin D
- parathyroid gland disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DVitamin D3 (Vi-De 3®. WILD) 6000IU daily over a period of 12 weeks. | Dietary supplement | Vitamin D |
| Placeboalcohol-based solution 1.3ml daily over a period of 12 weeks. | Dietary supplement | Placebo |
Primary outcome
peak power
Time frame: delta change from pre to 12 weeks post supplementation
peak power measured during wingate test
maximum torque
Time frame: delta change from pre to 12 weeks post supplementation
maximum torque measured with dynamometer
3 secondary outcomes
Vitamin D serum level
Time frame: week 0, 1 day before they start supplementation
Vitamin D serum level
Time frame: 12 weeks post supplementation
Count of injuries
Time frame: 12 weeks post supplementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with Vitamin D Deficiency and Spinal Cord Injury, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peak power (time frame: delta change from pre to 12 weeks post supplementation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2016; AzTrials last refreshed its copy on 7 Nov 2026.