Efficacy of Vitamin D3 Supplementation in Elevating Circulating 25(OH)D Concentration in Individuals With Chronic Spinal Cord Injury (VitD-SCI): Evidence From a Randomized, Double-Blind, Placebo-Controlled Trial
Abstract
Background: Individuals with spinal cord injury (SCI) are at increased risk for insufficient 25(OH)D levels and associated adverse health outcomes, highlighting the need for vitamin D supplementation. However, the optimal dosing strategy for vitamin D supplementation in this population remains unclear.
Objectives: To evaluate the efficacy of medium-dose (MD) and high-dose (HD) vitamin D3 supplementation in raising 25(OH)D levels above the sufficiency threshold of 75 nmol/L in individuals with SCI.
Methods: A 12-month randomized, double-blind, placebo-controlled, superiority clinical trial was conducted in 42 individuals living with SCI for at least 3 years and who had insufficient 25(OH)D levels at baseline. Participants (7 female, 35 male; age 48 ± 10 years; 32 with paraplegia, 10 with tetraplegia) were randomly assigned to the placebo, MD intervention (24,000 IU D3 once every 4 weeks), or HD intervention (24,000 IU D3 once every 2 weeks) group. Baseline 25(OH)D levels (43 ± 16 nmol/L) did not differ between intervention groups (P = .8).
Results: Supplementation was well tolerated, and 25(OH)D levels remained well below the excess threshold. A dose-response effect on 25(OH)D levels was observed [F(2, 40) = 8.21, P < .001]. In the HD group, 46% of the participants reached sufficient levels. Participants having an incomplete lesion, higher baseline 25(OH)D levels, lower body mass index, supplementation during summer, autumn, or winter, or higher sun scores were more likely to…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 42 participants or records.
Read the paper
Related studies
- Effectiveness of Bisphosphonates and Denosumab on Risk of Vertebral Fractures in Prostate Cancer Patients Under Androgen Deprivation Therapies: A Real-World Prospective Study
- Osteoporosis-related fractures after spinal cord injury: a retrospective study from Brazil
- Serum 25-hydroxyvitamin D, parathyroid hormone, and mortality in older men
- Lack of Association between Vitamin D Insufficiency and Cardiovascular or Fracture Risk: A UK Biobank Study
- Muscle strength and body composition are clinical indicators of osteoporosis
- Incidence of bone protection and associated fragility injuries in patients with proximal femur fractures
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.