Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, 6207, Switzerland
NCT Number: NCT04652544
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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Notify Me18 year–60 year
All sexes
Interventional
Phase 3
Nottwil, Canton of Lucerne, 6207, Switzerland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Vi-De 3® Monthly Dose from Dr. Wild & Co. AG (Muttenz, Switzerland) is a commercially available vitamin D3 supplement.
Other names: Vi-De 3® Monthly Dose
A placebo will be produced, consisting of the same ethanol solution as Vi-De 3® Monthly Dose, but without cholecalciferol.
Time frame: 0 to 12 months
Serum levels of 25(OH)D in nmol/L
Time frame: At baseline and after 12 months
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 0, 3, 6, 9, 12 months
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
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
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
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
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
The mean of three measurements of both hands will be measured in kg
Time frame: At 0, 3, 6, 9, 12 months
The incidence, reason (recreation or daily activity), possible injuries and care needed resulting from each fall since the last visit is assessed by several questions.
Time frame: At 0, 3, 6, 9, 12 months
Functional independence during daily living will be assessed by the Spinal Cord Independence Measure (SCIM, 3rd version)
Time frame: At 0, 3, 6, 9, 12 months
Serum levels of calcium (mmol/L) to monitor hypercalcemia
Time frame: At 0, 3, 6, 9, 12 months
Serum levels of parathyroid hormone (ng/L) will be monitored as it is correlated to vitamin vitamin D status
Time frame: At 0, 3, 6, 9, 12 months
Serum levels of phosphate (mmol/L) will be monitored as it is correlated to vitamin D status
Time frame: At 0, 3, 6, 9, 12 months
Serum levels of cystatin C (mg/L) to monitor kidney function
Time frame: At 0, 3, 6, 9, 12 months
Serum levels of estimated glomerular filtration rate (eGFR) (mL/min) to monitor kidney function
Time frame: At 0, 3, 6, 9, 12 months
Serum levels of testosterone (ng/dL) will be monitored as it is correlated to vitamin vitamin D status
Time frame: At 0, 3, 6, 9, 12 months
The occurrence of urinary tract infections since the last visit 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).
Time frame: At 0, 3, 6, 9, 12 months
The time spent outdoors (min) with level of exposed skin during the last 7 days, following Hanwell et al (2010).
Time frame: At 0 months
Six categories ranging from light to very dark skin types based on Fitzpatrick (1975)
Time frame: At 0 months
Time since SCI (years), neurological level of injury (NLI), and the degree of impairment following the American Spinal Injury Association (ASIA) Impairment Scale (AIS)
Time frame: At 0, 3, 6, 9, 12 months
Physical activity (hours and number of trainings), medication and nutritional supplements, and illnesses will be assessed by questionnaire. Weight will be measured on a scale.
Swiss Paraplegic Research, Nottwil
Network
Vitamin D Supplementation in Individuals With a Chronic Spinal Cord Injury - a Placebo-controlled Randomized Double-blinded Study
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