No discernible effect of vitamin D supplementation on secondary outcomes in chronic spinal cord injury: Findings from a randomized controlled trial.
Publisher DOI
PubMed ID
41032389
Abstract
Context
Sufficient vitamin D levels (serum 25(OH)D>75 nmol/L) have been associated with secondary health conditions and functional outcomes in individuals with chronic spinal cord injury (SCI). This study evaluated the effects of vitamin D3 supplementation on these outcomes.
Design
Randomized, placebo-controlled, double-blind clinical trial.
Setting
Specialized SCI center.
Participants
Participants included 42 individuals living with SCI for at least three years and exhibiting insufficient 25(OH)D levels at baseline (seven females, 35 males, mean age 48±10 years, 10 with tetraplegia, 32 with paraplegia).
Interventions
Participants were randomly assigned to receive placebo, medium-dose (24'000 IU every four weeks), or high-dose (24'000 IU every two weeks) vitamin D3 supplementation for 12 months.
Outcome Measures
For 12 months, the following parameters were evaluated at three-month intervals: 25(OH)D levels; occurrence of urinary tract infections, pressure injuries, falls, and pain; handgrip strength; functional independence; levels of fatigue, anxiety, and depression.
Results
Of the participants who received supplementation, 33% achieved sufficient 25(OH)D levels. Pain was reported by 79% of participants during the study, while falls (57%), urinary tract infections (55%), and pressure injuries (21%) were reported less frequently. Vitamin D3 supplementation demonstrated no measurable effect on any of the investigated parameters (all P-values ≥ 0.19).
Conclusion
Vitamin D3 supplementation resulted in sufficient 25(OH)D levels in only a minority of participants, which may account for the absence of effects on secondary outcomes relevant to SCI. Future studies should investigate the efficacy of higher supplementation doses, particularly for individuals with clinically relevant levels of the respective outcomes.Trial registration: The study was registered at ClinicalTrials.gov (registration ID: NCT04652544).
Sufficient vitamin D levels (serum 25(OH)D>75 nmol/L) have been associated with secondary health conditions and functional outcomes in individuals with chronic spinal cord injury (SCI). This study evaluated the effects of vitamin D3 supplementation on these outcomes.
Design
Randomized, placebo-controlled, double-blind clinical trial.
Setting
Specialized SCI center.
Participants
Participants included 42 individuals living with SCI for at least three years and exhibiting insufficient 25(OH)D levels at baseline (seven females, 35 males, mean age 48±10 years, 10 with tetraplegia, 32 with paraplegia).
Interventions
Participants were randomly assigned to receive placebo, medium-dose (24'000 IU every four weeks), or high-dose (24'000 IU every two weeks) vitamin D3 supplementation for 12 months.
Outcome Measures
For 12 months, the following parameters were evaluated at three-month intervals: 25(OH)D levels; occurrence of urinary tract infections, pressure injuries, falls, and pain; handgrip strength; functional independence; levels of fatigue, anxiety, and depression.
Results
Of the participants who received supplementation, 33% achieved sufficient 25(OH)D levels. Pain was reported by 79% of participants during the study, while falls (57%), urinary tract infections (55%), and pressure injuries (21%) were reported less frequently. Vitamin D3 supplementation demonstrated no measurable effect on any of the investigated parameters (all P-values ≥ 0.19).
Conclusion
Vitamin D3 supplementation resulted in sufficient 25(OH)D levels in only a minority of participants, which may account for the absence of effects on secondary outcomes relevant to SCI. Future studies should investigate the efficacy of higher supplementation doses, particularly for individuals with clinically relevant levels of the respective outcomes.Trial registration: The study was registered at ClinicalTrials.gov (registration ID: NCT04652544).
Date Issued
2025-10-01
Publication Type
Article
Subject(s)
Subjects
Cholecalciferol
•
clinical decision-making
•
micronutrient
•
paraplegia
•
tetraplegia
Language(s)
en
Author(s)
Hertig-Godeschalk, Anneke | |
Flueck, Joelle L | |
Brinkhof, Martin W G |
Additional Credits
Journal
The Journal of Spinal Cord Medicine
Publisher
Taylor and Francis Group
ISSN
2045-7723
1079-0268
Access(Rights)
restricted