Clinical trial NCT04652544: Vitamin D Supplementation in Individuals With a Chronic Spinal Cord Injury
Official title: Vitamin D Supplementation in Individuals With a Chronic Spinal Cord Injury - a Placebo-controlled Randomized Double-blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Spinal Cord Injuries
Vitamin D Deficiency
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
First posted: 2020-12-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants having a vitamin D status ≤ 75 nmol/L at baseline, will be randomly assigned to one of the three intervention groups.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility 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 (\> 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

Primary outcomes:
measure: Vitamin D status
timeFrame: 0 to 12 months
Secondary outcomes:
measure: Bone density
timeFrame: At baseline and after 12 months
measure: Mood
timeFrame: At 0, 3, 6, 9, 12 months
measure: Fatigue
timeFrame: At 0, 3, 6, 9, 12 months
measure: Chronic pain
timeFrame: At 0, 3, 6, 9, 12 months
measure: Recent pain
timeFrame: At 0, 3, 6, 9, 12 months
measure: Pressure injuries
timeFrame: At 0, 3, 6, 9, 12 months
Other outcomes:
measure: Handgrip strength
timeFrame: At 0, 3, 6, 9, 12 months
measure: Falls
timeFrame: At 0, 3, 6, 9, 12 months
measure: Functional independence
timeFrame: At 0, 3, 6, 9, 12 months
measure: Calcium status
timeFrame: At 0, 3, 6, 9, 12 months
measure: Parathyroid hormone status
timeFrame: At 0, 3, 6, 9, 12 months
measure: Phosphate status
timeFrame: At 0, 3, 6, 9, 12 months
measure: Cystatin C status
timeFrame: At 0, 3, 6, 9, 12 months
measure: Estimated glomerular filtration rate (eGFR) status
timeFrame: At 0, 3, 6, 9, 12 months
measure: Testosterone status
timeFrame: At 0, 3, 6, 9, 12 months
measure: Urinary tract infections
timeFrame: At 0, 3, 6, 9, 12 months
measure: Sun exposure
timeFrame: At 0, 3, 6, 9, 12 months
measure: Skin phototype
timeFrame: At 0 months
measure: SCI characteristics
timeFrame: At 0 months
measure: Personal characteristics
timeFrame: At 0, 3, 6, 9, 12 months
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Centre
state: Luzern
Study officials:
affiliation: Head physician paraplegiology
name: Anke Scheel-Sailer, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.