Vitamin D Supplementation in Individuals With a Chronic Spinal Cord Injury

March 7, 2024 updated by: Swiss Paraplegic Research, Nottwil

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Vitamin D status
Time Frame: 0 to 12 months
Serum levels of 25(OH)D in nmol/L
0 to 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
At baseline and after 12 months
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.
At 0, 3, 6, 9, 12 months
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.
At 0, 3, 6, 9, 12 months
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.
At 0, 3, 6, 9, 12 months
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.
At 0, 3, 6, 9, 12 months
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.
At 0, 3, 6, 9, 12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Handgrip strength
Time Frame: At 0, 3, 6, 9, 12 months
The mean of three measurements of both hands will be measured in kg
At 0, 3, 6, 9, 12 months
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.
At 0, 3, 6, 9, 12 months
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)
At 0, 3, 6, 9, 12 months
Calcium status
Time Frame: At 0, 3, 6, 9, 12 months
Serum levels of calcium (mmol/L) to monitor hypercalcemia
At 0, 3, 6, 9, 12 months
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
At 0, 3, 6, 9, 12 months
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
At 0, 3, 6, 9, 12 months
Cystatin C status
Time Frame: At 0, 3, 6, 9, 12 months
Serum levels of cystatin C (mg/L) to monitor kidney function
At 0, 3, 6, 9, 12 months
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
At 0, 3, 6, 9, 12 months
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
At 0, 3, 6, 9, 12 months
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).
At 0, 3, 6, 9, 12 months
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).
At 0, 3, 6, 9, 12 months
Skin phototype
Time Frame: At 0 months
Six categories ranging from light to very dark skin types based on Fitzpatrick (1975)
At 0 months
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)
At 0 months
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.
At 0, 3, 6, 9, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Swiss Paraplegic Research, Nottwil

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anke Scheel-Sailer, Dr. med., Head physician paraplegiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 19, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 23, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 23, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 3, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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