Vitamin D Supplementation in Individuals With a Chronic Spinal Cord Injury

Swiss Paraplegic Research, Nottwil

Status and phase: Completed; Phase 3

Conditions: Spinal Cord Injuries; Vitamin D Deficiency

Treatments: Other: Placebo; Drug: Cholecalciferol (Vitamin D3)

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT04652544

2020-06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 3 patient groups, including a placebo group

"Low" dose

Experimental group

Description:

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

Treatment:

Other: Placebo

Drug: Cholecalciferol (Vitamin D3)

"High" dose

Experimental group

Description:

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

Treatment:

Drug: Cholecalciferol (Vitamin D3)

Placebo

Placebo Comparator group

Description:

Two vials with a placebo every month.

Treatment:

Other: Placebo