NCT04652544

Vitamin D Supplementation in Individuals With a Chronic Spinal Cord Injury

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Swiss Paraplegic Research, Nottwil · Network
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Spinal Cord Injuries
• Vitamin D Deficiency

Interventions

Type	Name	Description
DRUG	Cholecalciferol (Vitamin D3)	Vi-De 3® Monthly Dose from Dr. Wild \& Co. AG (Muttenz, Switzerland) is a commercially available vitamin D3 supplement.
OTHER	Placebo	A placebo will be produced, consisting of the same ethanol solution as Vi-De 3® Monthly Dose, but without cholecalciferol.

Timeline

• Start date: 2021-05-19
• Primary completion: 2024-01-23
• Completion: 2024-01-23
• First posted: 2020-12-03
• Last updated: 2024-03-08

Locations

1 site across 1 country: Switzerland