Vitamin D Supplementation in Individuals With a Chronic Spinal Cord Injury
Primary Purpose
Spinal Cord Injuries, Vitamin D Deficiency
Status
Active
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
Cholecalciferol (Vitamin D3)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries
Eligibility 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
Sites / Locations
- Swiss Paraplegic Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
"Low" dose
"High" dose
Placebo
Arm Description
One vial with 600 µg cholecalciferol (corresponding to a total of 24'000 IU vitamin D) and one vial with placebo every month.
Two vials with 600 µg cholecalciferol each (corresponding to a total of 48'000 IU vitamin D) every month.
Two vials with a placebo every month.
Outcomes
Primary Outcome Measures
Vitamin D status
Serum levels of 25(OH)D in nmol/L
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04652544
First Posted
November 24, 2020
Last Updated
June 5, 2023
Sponsor
Swiss Paraplegic Research, Nottwil
1. Study Identification
Unique Protocol Identification Number
NCT04652544
Brief Title
Vitamin D Supplementation in Individuals With a Chronic Spinal Cord Injury
Official Title
Vitamin D Supplementation in Individuals With a Chronic Spinal Cord Injury - a Placebo-controlled Randomized Double-blinded Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 19, 2021 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Paraplegic Research, Nottwil
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Vitamin D Deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
"Low" dose
Arm Type
Experimental
Arm Description
One vial with 600 µg cholecalciferol (corresponding to a total of 24'000 IU vitamin D) and one vial with placebo every month.
Arm Title
"High" dose
Arm Type
Experimental
Arm Description
Two vials with 600 µg cholecalciferol each (corresponding to a total of 48'000 IU vitamin D) every month.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Two vials with a placebo every month.
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol (Vitamin D3)
Other Intervention Name(s)
Vi-De 3® Monthly Dose
Intervention Description
Vi-De 3® Monthly Dose from Dr. Wild & Co. AG (Muttenz, Switzerland) is a commercially available vitamin D3 supplement.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
A placebo will be produced, consisting of the same ethanol solution as Vi-De 3® Monthly Dose, but without cholecalciferol.
Primary Outcome Measure Information:
Title
Vitamin D status
Description
Serum levels of 25(OH)D in nmol/L
Time Frame
0 to 12 months
Secondary Outcome Measure Information:
Title
Bone density
Description
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.
Time Frame
At baseline and after 12 months
Title
Mood
Description
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.
Time Frame
At 0, 3, 6, 9, 12 months
Title
Fatigue
Description
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.
Time Frame
At 0, 3, 6, 9, 12 months
Title
Chronic pain
Description
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.
Time Frame
At 0, 3, 6, 9, 12 months
Title
Recent pain
Description
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.
Time Frame
At 0, 3, 6, 9, 12 months
Title
Pressure injuries
Description
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.
Time Frame
At 0, 3, 6, 9, 12 months
Other Pre-specified Outcome Measures:
Title
Handgrip strength
Description
The mean of three measurements of both hands will be measured in kg
Time Frame
At 0, 3, 6, 9, 12 months
Title
Falls
Description
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.
Time Frame
At 0, 3, 6, 9, 12 months
Title
Functional independence
Description
Functional independence during daily living will be assessed by the Spinal Cord Independence Measure (SCIM, 3rd version)
Time Frame
At 0, 3, 6, 9, 12 months
Title
Calcium status
Description
Serum levels of calcium (mmol/L) to monitor hypercalcemia
Time Frame
At 0, 3, 6, 9, 12 months
Title
Parathyroid hormone status
Description
Serum levels of parathyroid hormone (ng/L) will be monitored as it is correlated to vitamin vitamin D status
Time Frame
At 0, 3, 6, 9, 12 months
Title
Phosphate status
Description
Serum levels of phosphate (mmol/L) will be monitored as it is correlated to vitamin D status
Time Frame
At 0, 3, 6, 9, 12 months
Title
Cystatin C status
Description
Serum levels of cystatin C (mg/L) to monitor kidney function
Time Frame
At 0, 3, 6, 9, 12 months
Title
Estimated glomerular filtration rate (eGFR) status
Description
Serum levels of estimated glomerular filtration rate (eGFR) (mL/min) to monitor kidney function
Time Frame
At 0, 3, 6, 9, 12 months
Title
Testosterone status
Description
Serum levels of testosterone (ng/dL) will be monitored as it is correlated to vitamin vitamin D status
Time Frame
At 0, 3, 6, 9, 12 months
Title
Urinary tract infections
Description
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).
Time Frame
At 0, 3, 6, 9, 12 months
Title
Sun exposure
Description
The time spent outdoors (min) with level of exposed skin during the last 7 days, following Hanwell et al (2010).
Time Frame
At 0, 3, 6, 9, 12 months
Title
Skin phototype
Description
Six categories ranging from light to very dark skin types based on Fitzpatrick (1975)
Time Frame
At 0 months
Title
SCI characteristics
Description
Time since SCI (years), neurological level of injury (NLI), and the degree of impairment following the American Spinal Injury Association (ASIA) Impairment Scale (AIS)
Time Frame
At 0 months
Title
Personal characteristics
Description
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.
Time Frame
At 0, 3, 6, 9, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anke Scheel-Sailer, Dr. med.
Organizational Affiliation
Head physician paraplegiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Swiss Paraplegic Centre
City
Nottwil
State/Province
Luzern
ZIP/Postal Code
6207
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34921084
Citation
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.
Results Reference
derived
Learn more about this trial
Vitamin D Supplementation in Individuals With a Chronic Spinal Cord Injury
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