Vitamin D Supplementation in Individuals With a Chronic Spinal Cord Injury

NCT04652544 | Completed Phase 3

• 1 other identifier: 2020-06
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Vitamin D status

  Serum levels of 25(OH)D in nmol/L

  0 to 12 months

Secondary Outcomes (6)

• Bone density

  At baseline and after 12 months

• Mood

  At 0, 3, 6, 9, 12 months

• Fatigue

  At 0, 3, 6, 9, 12 months

• Chronic pain

  At 0, 3, 6, 9, 12 months

• Recent pain

  At 0, 3, 6, 9, 12 months

Other Outcomes (14)

• Handgrip strength

  At 0, 3, 6, 9, 12 months

• Falls

  At 0, 3, 6, 9, 12 months

• Functional independence

  At 0, 3, 6, 9, 12 months

Study Arms (3)

"Low" dose

EXPERIMENTAL

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

Drug: Cholecalciferol (Vitamin D3); Other: Placebo

"High" dose

EXPERIMENTAL

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

Drug: Cholecalciferol (Vitamin D3)

Placebo

PLACEBO COMPARATOR

Two vials with a placebo every month.

Other: Placebo

Interventions

Cholecalciferol (Vitamin D3) DRUG

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

Also known as: Vi-De 3® Monthly Dose

"High" dose; "Low" dose

Placebo OTHER

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

"Low" dose; Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Swiss Paraplegic Research, Nottwil: lead

Study Sites (1)

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

Related Publications (2)

• Hertig-Godeschalk A, Flueck JL, Scheel-Sailer A, Perret C, Brinkhof MWG. No discernible effect of vitamin D supplementation on secondary outcomes in chronic spinal cord injury: Findings from a randomized controlled trial. J Spinal Cord Med. 2025 Oct 1:1-12. doi: 10.1080/10790268.2025.2557078. Online ahead of print.

  PMID: 41032389 DERIVED

• Hertig-Godeschalk A, Brinkhof MWG, Scheel-Sailer A, Perret C, Jenny A, Landmann G, Wyss PO, Flueck JL. Vitamin D supplementation in chronic spinal cord injury (VitD-SCI): study protocol for a randomised controlled trial. BMJ Open. 2021 Dec 17;11(12):e053951. doi: 10.1136/bmjopen-2021-053951.

  PMID: 34921084 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Anke Scheel-Sailer, Dr. med.

  Head physician paraplegiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 3, 2020
• Study Start: May 19, 2021
• Primary Completion: January 23, 2024
• Study Completion: January 23, 2024
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)