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Completed

NCT Number: NCT04652544

Vitamin D Supplementation in Individuals With a Chronic Spinal Cord Injury

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cholecalciferol (vitamin D3)

Drug

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

Other

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

Primary outcomes

  1. Vitamin D status

    Time frame: 0 to 12 months

    Serum levels of 25(OH)D in nmol/L

Secondary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Swiss Paraplegic Research, Nottwil

Network

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 3, 2020
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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