drugset / Trial / NCT04652544
Vitamin D Supplementation in Individuals With a Chronic Spinal Cord Injury
RandomizedParallel-groupQuadruple-blindTreatment
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). 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.
Timeline
- Start
- 2021-05-19
- Primary completion
- 2024-01-23
- Completion
- 2024-01-23
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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cholecalciferol | Other / unclassified | 24000 iu | — |
| Subject | Cholecalciferol | Other / unclassified | 48000 iu | — |