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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
Vi-De 3® Monthly Dose from Dr. Wild \& Co. AG (Muttenz, Switzerland) is a commercially available vitamin D3 supplement.
A placebo will be produced, consisting of the same ethanol solution as Vi-De 3® Monthly Dose, but without cholecalciferol.
Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, Switzerland
Vitamin D status
Serum levels of 25(OH)D in nmol/L
Time frame: 0 to 12 months
Bone density
Measurements of the forearm (radius), hip (femoral neck) and knee (distal femur and proximal tibia) will be performed using dual-energy X-ray absorptiometry (DXA) scans. T-values will be reported.
Time frame: At baseline and after 12 months
Mood
Assessed by the Hospital Anxiety and Depression Scale (HADS) questionnaire, using a 4-step scale (1-4) with a total range of 14-56 and higher scores indicating worse outcomes.
Time frame: At 0, 3, 6, 9, 12 months
Fatigue
Assessed by the Fatigue Severity Scale (FSS) questionnaire, using a 8-step scale (1-7) with total range 9-63 and higher scores indicating worse outcomes.
Time frame: At 0, 3, 6, 9, 12 months
Chronic pain
The occurrence of pain since the last visit is assessed by one question of the SCI Secondary Conditions Scale (Kalpakjian, Scelza et al. 2007), providing a five-step rating (0-4) with a higher score indicating a worse outcome.
Time frame: At 0, 3, 6, 9, 12 months
Recent pain
The occurrence, kind, location and interference of pain during the last week is assessed using questions of the adapted version of the International SCI Pain Basic Data Set (Widerström-Noga, Biering-Sørensen et al. 2008). The interference of pain is measured on a 11-step scale (0-10), with total range 0-30 and higher scores indicating worse outcomes.
Time frame: At 0, 3, 6, 9, 12 months
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Pressure injuries
The occurrence, localization and severity of pressure injuries is assessed by the exact questions of the first-wave questionnaire of the Swiss Spinal Cord Injury Cohort Study (SwiSCI) survey (Post, Brinkhof et al. 2011, Brinkhof, Fekete et al. 2016). The severity or grade is assessed using the European and US National Pressure Ulcer Advisory panels' (EPUAP-NPUAP) classification (National Pressure Ulcer Advisory Panel and Alliance. 2014), using a 4 point scale (1-4) and higher grades indicating worse outcomes.
Time frame: At 0, 3, 6, 9, 12 months