Evidence map›Paper›PMID 34921084›Full record

ArticleBMJ open2021

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

Anneke Hertig-Godeschalk, Martin W G Brinkhof, Anke Scheel-Sailer, Claudio Perret, Andreas Jenny, Gunter Landmann, Patrik O Wyss, Joelle Leonie Flueck

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04652544 (Vitamin D Supplementation in Individuals With a Chronic Spinal Cord Injury - a Placebo-controlled Randomized Double-blinded Study), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04652544 phase3completednot on this map

Vitamin D Supplementation in Individuals With a Chronic Spinal Cord Injury - a Placebo-controlled Randomized Double-blinded Study

TypeinterventionalSponsorSwiss Paraplegic Research, NottwilRan2021 to 2024Enrolled50ConditionsSpinal Cord Injuries, Vitamin D DeficiencyArmsCholecalciferol (Vitamin D3), Placebo
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Nutritional interventions for preventing and treating pressure ulcers.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Observational
  6. Article
  7. Review
  8. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Anneke Hertig-GodeschalkInstitute of Sports Medicine, Swiss Paraplegic Centre, Nottwil, Switzerland.ORCID 0000-0002-4337-3865
Martin W G BrinkhofSwiss Paraplegic Research, Nottwil, Switzerland.
Anke Scheel-SailerDepartment of Health Sciences and Medicine, University of Lucerne, Luzerne, Switzerland.
Claudio PerretInstitute of Sports Medicine, Swiss Paraplegic Centre, Nottwil, Switzerland.
Andreas JennyDepartment of Rehabilitation, Swiss Paraplegic Centre, Nottwil, Switzerland.
Gunter LandmannCentre for Pain Medicine, Swiss Paraplegic Centre, Nottwil, Switzerland.
Patrik O WyssDepartment of Radiology, Swiss Paraplegic Centre, Nottwil, Switzerland.
Joelle Leonie FlueckInstitute of Sports Medicine, Swiss Paraplegic Centre, Nottwil, Switzerland joelle.flueck@sportmedizin-nottwil.ch.ORCID 0000-0002-6401-4490
Swiss Paraplegic Center · CHUniversity of Lucerne · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionVitamin 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.

Indexed as

Spinal Cord InjuriesVitamin D DeficiencyCholecalciferolDietary SupplementsEquivalence Trials as TopicHand StrengthHumansRandomized Controlled Trials as TopicVitamin DCholecalciferolVitamin Dcalcium & bonenutrition & dieteticspreventive medicineRehabilitation medicine

Identifiers

PMID34921084
PMCPMC8685947
OpenAlexW4200207838

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.