Spinal Cord Injuries, Vitamin D Deficiency
Conditions
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.
Interventions
Vi-De 3® Monthly Dose from Dr. Wild & Co. AG (Muttenz, Switzerland) is a commercially available vitamin D3 supplement.
OTHERPlacebo
A placebo will be produced, consisting of the same ethanol solution as Vi-De 3® Monthly Dose, but without cholecalciferol.
Sponsors
Swiss Paraplegic Research, Nottwil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vitamin D status | 0 to 12 months | Serum levels of 25(OH)D in nmol/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mood | 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. |
| Fatigue | 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. |
| Bone density | 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. |
| Recent pain | 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. |
| Pressure injuries | 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. |
| Chronic pain | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Estimated glomerular filtration rate (eGFR) status | At 0, 3, 6, 9, 12 months | Serum levels of estimated glomerular filtration rate (eGFR) (mL/min) to monitor kidney function |
| Testosterone status | 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 |
| Urinary tract infections | 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). |
| Handgrip strength | At 0, 3, 6, 9, 12 months | The mean of three measurements of both hands will be measured in kg |
| Skin phototype | At 0 months | Six categories ranging from light to very dark skin types based on Fitzpatrick (1975) |
| SCI characteristics | 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) |
| Personal characteristics | 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. |
| Sun exposure | 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). |
| Falls | 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. |
| Functional independence | At 0, 3, 6, 9, 12 months | Functional independence during daily living will be assessed by the Spinal Cord Independence Measure (SCIM, 3rd version) |
| Calcium status | At 0, 3, 6, 9, 12 months | Serum levels of calcium (mmol/L) to monitor hypercalcemia |
| Parathyroid hormone status | 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 |
| Phosphate status | At 0, 3, 6, 9, 12 months | Serum levels of phosphate (mmol/L) will be monitored as it is correlated to vitamin D status |
| Cystatin C status | At 0, 3, 6, 9, 12 months | Serum levels of cystatin C (mg/L) to monitor kidney function |
Countries
Switzerland
Outcome results
None listed