Vitamin D Supplementation in Individuals With a Chronic Spinal Cord Injury

• ClinicalTrials.gov Identifier: NCT04652544
• Recruitment Status: Recruiting
• First Posted: December 3, 2020
• Last Update Posted: November 26, 2021
• Sponsor: Swiss Paraplegic Centre Nottwil
• Information provided by (Responsible Party): Swiss Paraplegic Centre Nottwil

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Spinal Cord Injuries; Vitamin D Deficiency	Drug: Cholecalciferol (Vitamin D3); Other: Placebo	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Participants having a vitamin D status ≤ 75 nmol/L at baseline, will be randomly assigned to one of the three intervention groups.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Vitamin D Supplementation in Individuals With a Chronic Spinal Cord Injury - a Placebo-controlled Randomized Double-blinded Study
• Actual Study Start Date: May 19, 2021
• Estimated Primary Completion Date: June 2024
• Estimated Study Completion Date: June 2024

Arms and Interventions

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 Name: 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 Name: 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.

Outcome Measures

Primary Outcome Measures :

1. Vitamin D status [ Time Frame: 0 to 12 months ]
   Serum levels of 25(OH)D in nmol/L

Secondary Outcome Measures :

1. Bone density [ Time Frame: At baseline and after 12 months ]
   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.
2. Mood [ Time Frame: At 0, 3, 6, 9, 12 months ]
   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.
3. Fatigue [ Time Frame: At 0, 3, 6, 9, 12 months ]
   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.
4. Chronic pain [ Time Frame: At 0, 3, 6, 9, 12 months ]
   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.
5. Recent pain [ Time Frame: At 0, 3, 6, 9, 12 months ]
   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.
6. Pressure injuries [ Time Frame: At 0, 3, 6, 9, 12 months ]
   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.

Other Outcome Measures:

1. Handgrip strength [ Time Frame: At 0, 3, 6, 9, 12 months ]
   The mean of three measurements of both hands will be measured in kg
2. Falls [ Time Frame: At 0, 3, 6, 9, 12 months ]
   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.
3. Functional independence [ Time Frame: At 0, 3, 6, 9, 12 months ]
   Functional independence during daily living will be assessed by the Spinal Cord Independence Measure (SCIM, 3rd version)
4. Calcium status [ Time Frame: At 0, 3, 6, 9, 12 months ]
   Serum levels of calcium (mmol/L) to monitor hypercalcemia
5. Parathyroid hormone status [ Time Frame: At 0, 3, 6, 9, 12 months ]
   Serum levels of parathyroid hormone (ng/L) will be monitored as it is correlated to vitamin vitamin D status
6. Phosphate status [ Time Frame: At 0, 3, 6, 9, 12 months ]
   Serum levels of phosphate (mmol/L) will be monitored as it is correlated to vitamin D status
7. Cystatin C status [ Time Frame: At 0, 3, 6, 9, 12 months ]
   Serum levels of cystatin C (mg/L) to monitor kidney function
8. Estimated glomerular filtration rate (eGFR) status [ Time Frame: At 0, 3, 6, 9, 12 months ]
   Serum levels of estimated glomerular filtration rate (eGFR) (mL/min) to monitor kidney function
9. Testosterone status [ Time Frame: At 0, 3, 6, 9, 12 months ]
   Serum levels of testosterone (ng/dL) will be monitored as it is correlated to vitamin vitamin D status
10. Urinary tract infections [ Time Frame: At 0, 3, 6, 9, 12 months ]
    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).
11. Sun exposure [ Time Frame: At 0, 3, 6, 9, 12 months ]
    The time spent outdoors (min) with level of exposed skin during the last 7 days, following Hanwell et al (2010).
12. Skin phototype [ Time Frame: At 0 months ]
    Six categories ranging from light to very dark skin types based on Fitzpatrick (1975)
13. SCI characteristics [ Time Frame: At 0 months ]
    Time since SCI (years), neurological level of injury (NLI), and the degree of impairment following the American Spinal Injury Association (ASIA) Impairment Scale (AIS)
14. Personal characteristics [ Time Frame: At 0, 3, 6, 9, 12 months ]
    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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: Joëlle Flück, PhD; +41 41 939 66 17; joelle.flueck@paraplegie.ch

Contact: Anneke Hertig-Godeschalk, PhD; +41 41 939 66 03; anneke.hertig@paraplegie.ch

Locations

Switzerland

Swiss Paraplegic Centre; Recruiting

Nottwil, Luzern, Switzerland, 6207

Contact: Joëlle Flück, PhD +41 41 939 66 17 joelle.flueck@paraplegie.ch

Contact: Anneke Hertig-Godeschalk, PhD +41 41 939 66 03 anneke.hertig@paraplegie.ch

Sponsors and Collaborators

Swiss Paraplegic Centre Nottwil

Investigators

• Principal Investigator: Anke Scheel-Sailer, Dr. med.; Head physician paraplegiology

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Swiss Paraplegic Centre Nottwil
• ClinicalTrials.gov Identifier: NCT04652544
• Other Study ID Numbers: 2020-06
• First Posted: December 3, 2020
• Last Update Posted: November 26, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Spinal Cord Injuries; Vitamin D Deficiency; Wounds and Injuries; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Vitamin D; Cholecalciferol; Vitamins; Micronutrients; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents