Vitamin D Supplementation in Chronic Spinal Cord Injury (VitD-SCI): Study Protocol for a Randomised Controlled Trial

Overview

Journal BMJ Open

Specialty General Medicine

Date 2021 Dec 18

PMID 34921084

Citations 5

Authors

Anneke Hertig-Godeschalk

Martin W G Brinkhof

Anke Scheel-Sailer

Claudio Perret

Andreas Jenny

Gunter Landmann

Patrik O Wyss

Joelle Leonie Flueck

Affiliations

Soon will be listed here.

Abstract

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: NCT04652544 and SNCTP000004032.

Citing Articles

25-Hydroxyvitamin D Levels and Vitamin D3 Supplementation During Postacute Spinal Cord Injury Rehabilitation.

Hertig-Godeschalk A, Sailer C, Perret C, Lehnick D, Scheel-Sailer A, Flueck J Top Spinal Cord Inj Rehabil. 2024; 30(4):24-34.

PMID: 39619824 PMC: 11603107. DOI: 10.46292/sci24-00024.

Basal Metabolic Rate Versus Dietary Vitamin D and Calcium Intakes and the Association With Body Composition and Bone Health After Chronic Spinal Cord Injury.

Dora I, Khalil R, Adler R, Gorgey A Inquiry. 2024; 61:469580241278018.

PMID: 39264099 PMC: 11406582. DOI: 10.1177/00469580241278018.

Nutritional interventions for preventing and treating pressure ulcers.

Langer G, Wan C, Fink A, Schwingshackl L, Schoberer D Cochrane Database Syst Rev. 2024; 2:CD003216.

PMID: 38345088 PMC: 10860148. DOI: 10.1002/14651858.CD003216.pub3.

Mechanism of skeletal muscle atrophy after spinal cord injury: A narrative review.

Xu X, Talifu Z, Zhang C, Gao F, Ke H, Pan Y Front Nutr. 2023; 10:1099143.

PMID: 36937344 PMC: 10020380. DOI: 10.3389/fnut.2023.1099143.

Prevalence of vitamin D deficiency in patients with spinal cord injury at admission: a single-centred study in the UK.

Wong S, Dong H, Hirani S, Gainullina I, Ussef I, Graham A J Nutr Sci. 2023; 12:e24.

PMID: 36843972 PMC: 9947757. DOI: 10.1017/jns.2023.12.

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