Vitamin D Supplementation in Individuals With a Chronic Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04652544
• Other study ID #: 2020-06
• Status: Completed
• Phase: Phase 3
• Start date: May 19, 2021
• Est. completion date: January 23, 2024

Study information

• Verified date: March 2024
• Source: Swiss Paraplegic Research, Nottwil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 23, 2024
• Est. primary completion date: January 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Vitamin D Deficiency
• Wounds and Injuries

Intervention

Drug:
• Cholecalciferol (Vitamin D3)
Vi-De 3® Monthly Dose from Dr. Wild & Co. AG (Muttenz, Switzerland) is a commercially available vitamin D3 supplement.

Other:
• Placebo
A placebo will be produced, consisting of the same ethanol solution as Vi-De 3® Monthly Dose, but without cholecalciferol.

Locations

Country	Name	City	State
Switzerland	Swiss Paraplegic Centre	Nottwil	Luzern

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Paraplegic Research, Nottwil

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Handgrip strength	The mean of three measurements of both hands will be measured in kg	At 0, 3, 6, 9, 12 months
Other	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
Other	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
Other	Calcium status	Serum levels of calcium (mmol/L) to monitor hypercalcemia	At 0, 3, 6, 9, 12 months
Other	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
Other	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
Other	Cystatin C status	Serum levels of cystatin C (mg/L) to monitor kidney function	At 0, 3, 6, 9, 12 months
Other	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
Other	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
Other	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
Other	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
Other	Skin phototype	Six categories ranging from light to very dark skin types based on Fitzpatrick (1975)	At 0 months
Other	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
Other	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
Primary	Vitamin D status	Serum levels of 25(OH)D in nmol/L	0 to 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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