MedTrace Logo

Vitamin D Supplementation in Individuals With a Chronic Spinal Cord Injury

NCT04652544 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-03-08

No results posted yet for this study

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.

Conditions

  • Spinal Cord Injuries
  • Vitamin D Deficiency

Interventions

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.

Sponsors & Collaborators

  • Swiss Paraplegic Research, Nottwil

    lead NETWORK

Principal Investigators

  • Anke Scheel-Sailer, Dr. med. · Head physician paraplegiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-19
Primary Completion
2024-01-23
Completion
2024-01-23

Countries

  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04652544 on ClinicalTrials.gov