Vitamin D Supplementation in Individuals With a Chronic Spinal Cord Injury

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Swiss Paraplegic Centre Nottwil
• Treatments: Cholecalciferol; Vitamin D

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Contraindications to the investigational product

• Clinically relevant disorders,

• Pressure ulcer grade 3 or 4,

• Pregnancy, breastfeeding

• Vitamin D supplementation 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