Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Spinal Cord Injuries
  • Vitamin D Deficiency
Type
Interventional
Phase
Phase 3
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Participants having a vitamin D status ? 75 nmol/L at baseline, will be randomly assigned to one of the three intervention groups. Participants having a vitamin D status > 75 nmol/L at baseline, will be assigned to the natural time course group.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 60 years
Gender
Both males and females

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 ...

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 both a placebo group and a natural time course group as reference groups 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.

Tracking Information

NCT #
NCT04652544
Collaborators
Not Provided
Investigators
Principal Investigator: Anke Scheel-Sailer, Dr. med. Head physician paraplegiology
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