Vitamin D supplementation in chronic spinal cord injury (VitD-SCI): study protocol for a randomised controlled trial

BMJ Open, 2021 · DOI: 10.1136/bmjopen-2021-053951 · Published: November 29, 2021

Spinal Cord Injury Nutrition & Dietetics Rehabilitation

Simple Explanation

Vitamin D insufficiency is common in individuals with spinal cord injury (SCI) and can negatively impact musculoskeletal, immune, and respiratory systems. This study investigates the effect of vitamin D supplementation over 12 months on vitamin D status and secondary health parameters in individuals with chronic SCI. Participants will be randomly assigned to receive either a monthly dosage of 24 000 IU or 48 000 IU vitamin D, or a placebo.

Study Duration

12 months

Participants

45 individuals with chronic SCI

Evidence Level

Level 1, Randomized, placebo-controlled, double-blinded superiority trial

Key Findings

1
The primary outcome is the change in vitamin D status after 12 months of supplementation.
2
Secondary outcomes include bone mineral density, handgrip strength, fatigue, mood, pain, and pressure injuries.
3
The study will assess the safety and tolerance of vitamin D supplementation in individuals with chronic SCI.

Research Summary

This study protocol presents a randomised, placebo-controlled trial (VitD-SCI) to investigate the impact of 12 months of vitamin D supplementation on vitamin D status and secondary parameters in individuals with chronic spinal cord injury (SCI). The trial will involve 45 participants with chronic SCI who will be randomly assigned to receive either a monthly dosage of 24 000 IU or 48 000 IU of vitamin D, or a placebo. Measurements will be taken every 3 months to assess vitamin D status, bone mineral density, handgrip strength, fatigue, mood, pain, and pressure injuries, while also evaluating the safety and tolerance of vitamin D supplementation.

Practical Implications

Inform Clinical Recommendations

The study aims to provide insights for optimizing individual vitamin D supplementation strategies in chronic SCI.

Standardized Management

If a positive relation between vitamin D status and secondary outcomes is established, this could lead to standardized clinical recommendations.

Community-based Policy

The evidence acquired during this study will effectively inform community-based policy regarding vitamin D supplementation in chronic SCI.

Study Limitations

1
Adherence to the protocol cannot be objectively assessed due to the home-based setting.
2
Dietary vitamin D intake will not be assessed, precluding scaling of vitamin D efficacy to variations in nutrition.
3
Not all relevant clinical outcomes, such as respiratory and immune function, can be assessed due to feasibility.

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