Vitamin D Supplementation in Individuals With a Chronic Spinal Cord Injury

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

The main objective of this placebo-controlled randomized double-blinded study is to investigate the effect of vitamin D supplementation on vitamin D status (25(OH)D concentration in the blood) among individuals with a chronic spinal cord injury (SCI). Further, the effects of vitamin D supplementation on several other parameters (e.g. bone density and mood) are investigated, which could reveal positive secondary effects of supplementation that are especially relevant for clinical practice.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency; Spinal Cord Injuries
• Intervention / Treatment: Drug: Cholecalciferol (Vitamin D3); Other: Placebo

Detailed Description

The purpose of this study is to evaluate the influence of vitamin D supplementation among individuals with chronic SCI. The primary aim is to study whether different dosages (24'000 IU/month or 48'000 IU/month) of vitamin D supplementation over 12 months will lead to differences in vitamin D status as well as differences in several other outcomes. The use of a placebo group supports the evaluation of dose-response effects of vitamin D supplementation on the primary outcome (vitamin D status) and secondary outcomes (including bone density and mood) that are not only supported by randomized controlled trial standards but also informative in clinical practice.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Anneke Hertig-Godeschalk, PhD; Phone Number: +41 41 939 66 03; Email: anneke.hertig@paraplegie.ch

Study Locations

• Switzerland
  • Luzern
    • Nottwil, Luzern, Switzerland, 6207
      • Swiss Paraplegic Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Informed Consent to the present study as documented by a signature
• Chronic (> 3 years) traumatic or non-traumatic spinal cord injury with a sub-C4-level lesion
• Wheelchair dependency during activities of daily living
• vitamin D status <75nmol/L

Exclusion Criteria:

• Contraindications to the investigational product
• Clinically relevant disorders,
• Pressure ulcer grade 3 or 4
• Pregnancy, breastfeeding
• Vitamin D supplementation (> 400 IU/day) within the last 12 months
• Visiting a country with increased sun exposure (below the 37th parallel north) within the last month before study enrolment or during the study
• Fractures in both arms and/or both legs within the last five years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: "Low" dose; One vial with 600 µg cholecalciferol (corresponding to a total of 24'000 IU vitamin D) and one vial with placebo every month.	Drug: Cholecalciferol (Vitamin D3); Vi-De 3® Monthly Dose from Dr. Wild & Co. AG (Muttenz, Switzerland) is a commercially available vitamin D3 supplement.; Other Names: Vi-De 3® Monthly Dose; Other: Placebo; A placebo will be produced, consisting of the same ethanol solution as Vi-De 3® Monthly Dose, but without cholecalciferol.
Experimental: "High" dose; Two vials with 600 µg cholecalciferol each (corresponding to a total of 48'000 IU vitamin D) every month.	Drug: Cholecalciferol (Vitamin D3); Vi-De 3® Monthly Dose from Dr. Wild & Co. AG (Muttenz, Switzerland) is a commercially available vitamin D3 supplement.; Other Names: Vi-De 3® Monthly Dose
Placebo Comparator: Placebo; Two vials with a placebo every month.	Other: Placebo; A placebo will be produced, consisting of the same ethanol solution as Vi-De 3® Monthly Dose, but without cholecalciferol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vitamin D status	Serum levels of 25(OH)D in nmol/L	0 to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone density	Measurements of the forearm (radius), hip (femoral neck) and knee (distal femur and proximal tibia) will be performed using dual-energy X-ray absorptiometry (DXA) scans. T-values will be reported.	At baseline and after 12 months
Mood	Assessed by the Hospital Anxiety and Depression Scale (HADS) questionnaire, using a 4-step scale (1-4) with a total range of 14-56 and higher scores indicating worse outcomes.	At 0, 3, 6, 9, 12 months
Fatigue	Assessed by the Fatigue Severity Scale (FSS) questionnaire, using a 8-step scale (1-7) with total range 9-63 and higher scores indicating worse outcomes.	At 0, 3, 6, 9, 12 months
Chronic pain	The occurrence of pain since the last visit is assessed by one question of the SCI Secondary Conditions Scale (Kalpakjian, Scelza et al. 2007), providing a five-step rating (0-4) with a higher score indicating a worse outcome.	At 0, 3, 6, 9, 12 months
Recent pain	The occurrence, kind, location and interference of pain during the last week is assessed using questions of the adapted version of the International SCI Pain Basic Data Set (Widerström-Noga, Biering-Sørensen et al. 2008). The interference of pain is measured on a 11-step scale (0-10), with total range 0-30 and higher scores indicating worse outcomes.	At 0, 3, 6, 9, 12 months
Pressure injuries	The occurrence, localization and severity of pressure injuries is assessed by the exact questions of the first-wave questionnaire of the Swiss Spinal Cord Injury Cohort Study (SwiSCI) survey (Post, Brinkhof et al. 2011, Brinkhof, Fekete et al. 2016). The severity or grade is assessed using the European and US National Pressure Ulcer Advisory panels' (EPUAP-NPUAP) classification (National Pressure Ulcer Advisory Panel and Alliance. 2014), using a 4 point scale (1-4) and higher grades indicating worse outcomes.	At 0, 3, 6, 9, 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Handgrip strength	The mean of three measurements of both hands will be measured in kg	At 0, 3, 6, 9, 12 months
Falls	The incidence, reason (recreation or daily activity), possible injuries and care needed resulting from each fall since the last visit is assessed by several questions.	At 0, 3, 6, 9, 12 months
Functional independence	Functional independence during daily living will be assessed by the Spinal Cord Independence Measure (SCIM, 3rd version)	At 0, 3, 6, 9, 12 months
Calcium status	Serum levels of calcium (mmol/L) to monitor hypercalcemia	At 0, 3, 6, 9, 12 months
Parathyroid hormone status	Serum levels of parathyroid hormone (ng/L) will be monitored as it is correlated to vitamin vitamin D status	At 0, 3, 6, 9, 12 months
Phosphate status	Serum levels of phosphate (mmol/L) will be monitored as it is correlated to vitamin D status	At 0, 3, 6, 9, 12 months
Cystatin C status	Serum levels of cystatin C (mg/L) to monitor kidney function	At 0, 3, 6, 9, 12 months
Estimated glomerular filtration rate (eGFR) status	Serum levels of estimated glomerular filtration rate (eGFR) (mL/min) to monitor kidney function	At 0, 3, 6, 9, 12 months
Testosterone status	Serum levels of testosterone (ng/dL) will be monitored as it is correlated to vitamin vitamin D status	At 0, 3, 6, 9, 12 months
Urinary tract infections	The occurrence of urinary tract infections since the last visit is assessed by the exact questions of the first-wave questionnaire of the Swiss Spinal Cord Injury Cohort Study (SwiSCI) survey (Post, Brinkhof et al. 2011, Brinkhof, Fekete et al. 2016).	At 0, 3, 6, 9, 12 months
Sun exposure	The time spent outdoors (min) with level of exposed skin during the last 7 days, following Hanwell et al (2010).	At 0, 3, 6, 9, 12 months
Skin phototype	Six categories ranging from light to very dark skin types based on Fitzpatrick (1975)	At 0 months
SCI characteristics	Time since SCI (years), neurological level of injury (NLI), and the degree of impairment following the American Spinal Injury Association (ASIA) Impairment Scale (AIS)	At 0 months
Personal characteristics	Physical activity (hours and number of trainings), medication and nutritional supplements, and illnesses will be assessed by questionnaire. Weight will be measured on a scale.	At 0, 3, 6, 9, 12 months

Collaborators and Investigators

• Sponsor: Swiss Paraplegic Research, Nottwil
• Investigators: Principal Investigator: Anke Scheel-Sailer, Dr. med., Head physician paraplegiology

Publications and helpful links

General Publications

• Hertig-Godeschalk A, Brinkhof MWG, Scheel-Sailer A, Perret C, Jenny A, Landmann G, Wyss PO, Flueck JL. Vitamin D supplementation in chronic spinal cord injury (VitD-SCI): study protocol for a randomised controlled trial. BMJ Open. 2021 Dec 17;11(12):e053951. doi: 10.1136/bmjopen-2021-053951.

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2021
• Primary Completion (Actual): January 23, 2024
• Study Completion (Actual): January 23, 2024

Study Registration Dates

• First Submitted: November 24, 2020
• First Submitted That Met QC Criteria: December 2, 2020
• First Posted (Actual): December 3, 2020

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Nutrition Disorders; Trauma, Nervous System; Spinal Cord Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Wounds and Injuries; Vitamin D Deficiency; Spinal Cord Injuries; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: 2020-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No