Study design: Randomized, placebo-controlled, double-blind, parallel-group, superiority trial.
Objective: Sufficient vitamin D levels (serum 25(OH)D > 75 nmol/L) are essential for bone health. The prevalence of insufficient 25(OH)D levels and osteoporosis is high in individuals with spinal cord injury (SCI). This study presents secondary outcomes from the VitD-SCI trial, which evaluated the effect of two D3 supplementation doses over a 12-month period on bone mineral density (BMD) in individuals with chronic SCI.
Setting: Swiss SCI clinic.
Methods: Forty-two individuals living with SCI for at least three years (seven females, mean age 48 ± 10 years, 18 ± 13 years since SCI onset) and having insufficient 25(OH)D levels were included. Participants were randomized to receive placebo, medium-dose (24'000 IU once every four weeks), or high-dose (24'000 IU once every two weeks) D3 supplementation for 12 months. At baseline and 12 months, 25(OH)D levels and BMD (measured at the radius, femoral neck, distal femur, and proximal tibia) were assessed.
Results: Thirty-three percent of participants who received supplementation achieved sufficient 25(OH)D levels. No effect of D3 supplementation on BMD was observed when comparing baseline to 12 months, regardless of the measurement site. None of the investigated parameters, including lesion level or smoking status, modified the effect under examination.
Conclusion: Twelve months of D3 supplementation showed no effect on BMD in individuals with chronic SCI. This study highlights the complexity of SCI-specific physiological mechanisms that may interfere with the response to D3 supplementation and its impact on bone health in this population.
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