Vitamin D Supplementation in Individuals With a Chronic Spinal Cord Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-19

Study Completion Date

2024-01-23

Brief Summary

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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.

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Detailed Description

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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

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Spinal Cord Injuries Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants having a vitamin D status ≤ 75 nmol/L at baseline, will be randomly assigned to one of the three intervention groups.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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"Low" dose

One vial with 600 µg cholecalciferol (corresponding to a total of 24'000 IU vitamin D) and one vial with placebo every month.

Group Type EXPERIMENTAL

Cholecalciferol (Vitamin D3)

Intervention Type DRUG

Vi-De 3® Monthly Dose from Dr. Wild \& Co. AG (Muttenz, Switzerland) is a commercially available vitamin D3 supplement.

Placebo

Intervention Type OTHER

A placebo will be produced, consisting of the same ethanol solution as Vi-De 3® Monthly Dose, but without cholecalciferol.

"High" dose

Two vials with 600 µg cholecalciferol each (corresponding to a total of 48'000 IU vitamin D) every month.

Group Type EXPERIMENTAL

Cholecalciferol (Vitamin D3)

Intervention Type DRUG

Vi-De 3® Monthly Dose from Dr. Wild \& Co. AG (Muttenz, Switzerland) is a commercially available vitamin D3 supplement.

Placebo

Two vials with a placebo every month.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

A placebo will be produced, consisting of the same ethanol solution as Vi-De 3® Monthly Dose, but without cholecalciferol.

Interventions

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Cholecalciferol (Vitamin D3)

Vi-De 3® Monthly Dose from Dr. Wild \& Co. AG (Muttenz, Switzerland) is a commercially available vitamin D3 supplement.

Intervention Type DRUG

Placebo

A placebo will be produced, consisting of the same ethanol solution as Vi-De 3® Monthly Dose, but without cholecalciferol.

Intervention Type OTHER

Other Intervention Names

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Vi-De 3® Monthly Dose

Eligibility Criteria

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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 (\> 400 IU/day) 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No