Vitamin D supplementation in chronic spinal cord injury (VitD-SCI): study protocol for a randomised controlled trial
Introduction
Vitamin D insufficiency, a vitamin D status or serum 25(OH)D concentration of ≤75 nmol/L, is highly prevalent in individuals with a spinal cord injury (SCI). Vitamin D is important for the functioning of the musculoskeletal, immune and respiratory systems, which are relevant determinants of secondary health conditions in SCI. An insufficiency should be treated with vitamin D supplementation. However, there is a lack of evidence regarding the optimal dosage and duration of vitamin D supplementation for individualised and long-term management of the vitamin D status in the context of SCI. This paper presents the protocol for the vitamin D supplementation in chronic spinal cord injury (VitD-SCI) trial that aims to investigate the effect of a 12-month intake of vitamin D supplementation on vitamin D status as well as on several secondary parameters among individuals with a chronic SCI.
Methods and analyses
The VitD-SCI trial is a randomised, placebo-controlled, double-blinded, parallel-group, superiority trial, conducted at the Swiss Paraplegic Centre. A total of 45 participants living with an SCI for at least 3 years (chronic SCI) and a vitamin D insufficiency at the first study visit, will be randomly assigned to one of three intervention groups. Participants receive either a monthly dosage of 24 000 IU or 48 000 IU vitamin D or a placebo for 12 months. Measurements taking place every 3 months include the assessment of vitamin D status (primary outcome) as well as bone mineral density, handgrip strength, fatigue, mood, pain and pressure injuries (secondary outcomes). Safety and tolerance of vitamin D supplementation will also be evaluated.
Ethics and dissemination
The Swiss Ethics Committee for Northwest/Central Switzerland (EKNZ, 2020–01493) and the Swiss Agency for Therapeutic Products (Swissmedic, 2020DR3150) approved this study. Findings will be disseminated through peer-reviewed publications.
Trial registration numbers
Top-30
Journals
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Journal of Spinal Cord Medicine
2 publications, 18.18%
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Topics in Spinal Cord Injury Rehabilitation
2 publications, 18.18%
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Journal of Nutritional Science
1 publication, 9.09%
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Frontiers in Nutrition
1 publication, 9.09%
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Current Physical Medicine and Rehabilitation Reports
1 publication, 9.09%
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Cochrane Database of Systematic Reviews
1 publication, 9.09%
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Inquiry (United States)
1 publication, 9.09%
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Advances in Nutrition
1 publication, 9.09%
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Spinal Cord
1 publication, 9.09%
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Publishers
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Springer Nature
2 publications, 18.18%
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Taylor & Francis
2 publications, 18.18%
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American Spinal Injury Association
2 publications, 18.18%
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Cambridge University Press
1 publication, 9.09%
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Frontiers Media S.A.
1 publication, 9.09%
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Wiley
1 publication, 9.09%
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SAGE
1 publication, 9.09%
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Elsevier
1 publication, 9.09%
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