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Spinal Cord InjuriesPhase 3NCT04652544

Vitamin D Supplementation in Individuals With a Chronic Spinal Cord Injury

A Phase 3 study testing Cholecalciferol (Vitamin D3) in people with Spinal Cord Injuries and Vitamin D Deficiency, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main objective of this placebo-controlled randomized double-blinded study is to investigate the effect of vitamin D supplementation on vitamin D status (25(OH)D concentration in the blood) among individuals with a chronic spinal cord injury (SCI). Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Spinal Cord Injuries, Vitamin D Deficiency
What is being tested?
Cholecalciferol (Vitamin D3)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteSwitzerland
Study dates
19 May 2021to 23 Jan 2024
Phase
Phase 3
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Informed Consent to the present study as documented by a signature
  • Chronic (> 3 years) traumatic or non-traumatic spinal cord injury with a sub-C4-level lesion
  • Wheelchair dependency during activities of daily living
  • vitamin D status <75nmol/L

Who cannot join

  • Contraindications to the investigational product
  • Clinically relevant disorders,
  • Pressure ulcer grade 3 or 4
  • Pregnancy, breastfeeding
  • Vitamin D supplementation (> 400 IU/day) within the last 12 months
  • Visiting a country with increased sun exposure (below the 37th parallel north) within the last month before study enrolment or during the study
  • Fractures in both arms and/or both legs within the last five years

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Swiss Paraplegic Centre

    Nottwil, Canton of Lucerne, 6207

Other trials in Switzerland

About this study

Official title: Vitamin D Supplementation in Individuals With a Chronic Spinal Cord Injury - a Placebo-controlled Randomized Double-blinded Study

The main objective of this placebo-controlled randomized double-blinded study is to investigate the effect of vitamin D supplementation on vitamin D status (25(OH)D concentration in the blood) among individuals with a chronic spinal cord injury (SCI). Further, the effects of vitamin D supplementation on several other parameters (e.g. bone density and mood) are investigated, which could reveal positive secondary effects of supplementation that are especially relevant for clinical practice.

Read the detailed description

The purpose of this study is to evaluate the influence of vitamin D supplementation among individuals with chronic SCI. The primary aim is to study whether different dosages (24'000 IU/month or 48'000 IU/month) of vitamin D supplementation over 12 months will lead to differences in vitamin D status as well as differences in several other outcomes. The use of a placebo group supports the evaluation of dose-response effects of vitamin D supplementation on the primary outcome (vitamin D status) and secondary outcomes (including bone density and mood) that are not only supported by randomized controlled trial standards but also informative in clinical practice.

Being tested
Cholecalciferol (Vitamin D3), Placebo
Medical subject headings
Spinal Cord Injuries, Vitamin D Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cholecalciferol (Vitamin D3)Drug

    Also called Vi-De 3® Monthly Dose

    Vi-De 3® Monthly Dose from Dr. Wild \& Co. AG (Muttenz, Switzerland) is a commercially available vitamin D3 supplement.

  • PlaceboOther

    A placebo will be produced, consisting of the same ethanol solution as Vi-De 3® Monthly Dose, but without cholecalciferol.

Study groups in NCT04652544
Study groupRoleWhat they receive
"Low" doseExperimentalOne vial with 600 µg cholecalciferol (corresponding to a total of 24'000 IU vitamin D) and one vial with placebo every month.
Receives: Drug: Cholecalciferol (Vitamin D3); Other: Placebo
"High" doseExperimentalTwo vials with 600 µg cholecalciferol each (corresponding to a total of 48'000 IU vitamin D) every month.
Receives: Drug: Cholecalciferol (Vitamin D3)
PlaceboPlacebo comparatorTwo vials with a placebo every month.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vitamin D status

    Serum levels of 25(OH)D in nmol/L

    Measured: 0 to 12 months

Secondary outcomes (6)

  1. Bone density

    Measurements of the forearm (radius), hip (femoral neck) and knee (distal femur and proximal tibia) will be performed using dual-energy X-ray absorptiometry (DXA) scans. T-values will be reported.

    Measured: At baseline and after 12 months

  2. Mood

    Assessed by the Hospital Anxiety and Depression Scale (HADS) questionnaire, using a 4-step scale (1-4) with a total range of 14-56 and higher scores indicating worse outcomes.

    Measured: At 0, 3, 6, 9, 12 months

  3. Fatigue

    Assessed by the Fatigue Severity Scale (FSS) questionnaire, using a 8-step scale (1-7) with total range 9-63 and higher scores indicating worse outcomes.

    Measured: At 0, 3, 6, 9, 12 months

  4. Chronic pain

    The occurrence of pain since the last visit is assessed by one question of the SCI Secondary Conditions Scale (Kalpakjian, Scelza et al. 2007), providing a five-step rating (0-4) with a higher score indicating a worse outcome.

    Measured: At 0, 3, 6, 9, 12 months

  5. Recent pain

    The occurrence, kind, location and interference of pain during the last week is assessed using questions of the adapted version of the International SCI Pain Basic Data Set (Widerström-Noga, Biering-Sørensen et al. 2008). The interference of pain is measured on a 11-step scale (0-10), with total range 0-30 and higher scores indicating worse outcomes.

    Measured: At 0, 3, 6, 9, 12 months

  6. Pressure injuries

    The occurrence, localization and severity of pressure injuries is assessed by the exact questions of the first-wave questionnaire of the Swiss Spinal Cord Injury Cohort Study (SwiSCI) survey (Post, Brinkhof et al. 2011, Brinkhof, Fekete et al. 2016). The severity or grade is assessed using the European and US National Pressure Ulcer Advisory panels' (EPUAP-NPUAP) classification (National Pressure Ulcer Advisory Panel and Alliance. 2014), using a 4 point scale (1-4) and higher grades indicating worse outcomes.

    Measured: At 0, 3, 6, 9, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2020
  2. Study start19 May 2021
  3. Primary completion23 Jan 2024
  4. Study completion23 Jan 2024

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants having a vitamin D status ≤ 75 nmol/L at baseline, will be randomly assigned to one of the three intervention groups.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04652544
Sponsor's protocol ID
2020-06
Status last verified
Mar 2024
First submitted
24 Nov 2020
Last updated
8 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hertig-Godeschalk A, Flueck JL, Scheel-Sailer A, Perret C, Brinkhof MWG. No discernible effect of vitamin D supplementation on secondary outcomes in chronic spinal cord injury: Findings from a randomized controlled trial. J Spinal Cord Med. 2025 Oct 1:1-12. doi: 10.1080/10790268.2025.2557078. Online ahead of print.

    PubMed 41032389

  • Hertig-Godeschalk A, Brinkhof MWG, Scheel-Sailer A, Perret C, Jenny A, Landmann G, Wyss PO, Flueck JL. Vitamin D supplementation in chronic spinal cord injury (VitD-SCI): study protocol for a randomised controlled trial. BMJ Open. 2021 Dec 17;11(12):e053951. doi: 10.1136/bmjopen-2021-053951.

    PubMed 34921084

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cholecalciferol (Vitamin D3) in people with Spinal Cord Injuries and Vitamin D Deficiency, 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 8 Mar 2024. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Vitamin D status (time frame: 0 to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04652544, which also lists 2 linked publications.

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 8 Mar 2024.

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