Effect of vitamin D supplementation on the functional efficiency of patients after stroke
| ISRCTN | ISRCTN11086312 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11086312 |
- Submission date
- 16/02/2023
- Registration date
- 07/03/2023
- Last edited
- 24/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Stroke is the third leading cause of death in the adult population after heart disease and cancer. Post-stroke death rates in Poland are higher than in other European countries and the USA. Long-term disability is a serious problem among survivors. Studies have shown that almost 15-30% of people after a stroke are permanently disabled, and more than 20% of people require institutional help 3 months after the stroke. Vitamin D deficiency is now a widely recognized public health problem, affecting almost every second person worldwide. Recent evidence from multiple population studies indicates that vitamin D deficiency is a predictor of future strokes. The aim of this study is to find out whether vitamin D supplementation has an impact on patients undergoing neurological rehabilitation over 6 weeks.
Who can participate?
Patients aged 45-65 years who have had their first ischemic stroke and have been admitted to the ward for early post-stroke rehabilitation
What does the study involve?
Participants will undergo examinations including medical history, history and physical examination, and basic laboratory tests. They will be randomly allocated to one of two groups to take vitamin D supplements every morning (at 7.30 a.m.) for 6 weeks or to not take vitamin D supplements. Participants are assessed at the beginning of hospitalization and after 42 days.
What are the possible benefits and risks of participating?
For the safety of patients, blood pressure and heart rate will be measured before each unit of rehabilitation. Improvement training will always be selected individually for each patient to their current capabilities and needs, taking into account the patient's capabilities. Each of the patients qualified for rehabilitation in the Local Department of Neurological Rehabilitation may withdraw from participation in rehabilitation.
The results of the study will be used to participate in the discussion on modern forms of therapy used in patients after a stroke, their effectiveness, and the possibility of practical use on a wider scale.
Where is the study run from?
Regional Specialist Hospital in Wrocław, Local Department of Neurological Rehabilitation (Poland)
When is the study starting and how long is it expected to run for?
December 2022 to December 2023
Who is funding the study?
Wroclaw Medical University (Poland) - SUBZ.E060.23.037
Who is the main contact?
Prof. Małgorzata Paprocka-Borowicz, malgorzata.paprocka-borowicz@umw.edu.pl
Contact information
Principal Investigator
Chałubińskiego 3
Wroclaw
50-368
Poland
 ORCID ID |
0000-0003-4296-7052 |
|---|---|
| Phone | +48 (0)71 784 28 15 |
| malgorzata.paprocka-borowicz@umw.edu.pl |
Study information
| Study design | Single-center non-placebo-controlled prospective randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | The effect of vitamin D Supplementation on the fUnctional efficiency of Patients after ischemic strOke undergoing neurological Rehabilitation - a prospective, randomized Trial with a control group (D-SUPORT) |
| Study acronym | D-SUPORT |
| Study objectives | Vitamin D (25[OH]D) supplementation improves the functional efficiency of patients undergoing 6-week neurological rehabilitation better than no supplementation. |
| Ethics approval(s) | Approved 01/02/2023, Institutional Review Board at Wroclaw Medical University (ul. Pasteura 1, 50-367 Wrocław, Poland; +48 (0)71 784 17 10; bioetyka@umed.wroc.pl), ref: KB – 813/2022 |
| Health condition(s) or problem(s) studied | Patients who had their first ischemic stroke were admitted to the ward for early post-stroke rehabilitation |
| Intervention | Participants in the study will be randomized (using the randomization program from the website random.org) and assigned to one of two comparison groups: group A - a group in which vitamin D supplementation at a dose of 2000 IU every morning (at 7.30 a.m.) for 6 weeks and group B (control) - group without vitamin D supplementation. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 25-hydroxyvitamin D (25[OH]D) |
| Primary outcome measure | 1. Clinical symptoms in the course of stroke were assessed using the National Institute of Health Stroke Scale (NIHSS) at baseline and after the intervention and 1 and 3 months after the intervention 2. Everyday activity assessed using the Barthel Scale at baseline and after the intervention and 1 and 3 months after the intervention 3. Degree of disability assessed using the Modified Rankin Scale at baseline and after the intervention and 1 and 3 months after the intervention |
| Secondary outcome measures | Complete blood count, urine analysis, and concentration of 25(OH)D and IGF-1 measured using basic laboratory tests before and after the intervention at baseline and after the intervention and 1 and 3 months after the intervention |
| Overall study start date | 01/12/2022 |
| Completion date | 31/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 120 |
| Total final enrolment | 160 |
| Key inclusion criteria | 1. First ischemic stroke (time of occurrence 2 weeks before admission to the Department of Neurological Rehabilitation) 2. Stroke confirmed by MR or CT scan 3. Age >18 years old 4. No contraindications to participate in the experiment (consent of the attending physician) 5. No concomitant neurological diseases 6. Written informed consent of the patient to participate in the research |
| Key exclusion criteria | 1. Patients with infection in the last 2 weeks 2. Patients who have taken vitamin D and its derivatives or calcium in the last 3 months 3. Patients with liver and kidney disorders 4. Patients with thyroid dysfunction 5. Patients with aphasia 6. Patients who do not consent to the research |
| Date of first enrolment | 01/03/2023 |
| Date of final enrolment | 30/09/2023 |
Locations
Countries of recruitment
- Poland
Study participating centre
Wrocław
51-128
Poland
Sponsor information
University/education
Wybrzeże L. Pasteura 1
Wroclaw
50-367
Poland
| Phone | +48 (0)71 784 10 11 |
|---|---|
| ewelina.tyczynska@umw.edu.pl | |
| Website | https://www.umw.edu.pl/pl/jednostki/katedra-fizjoterapii |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Wroclaw Medical University
- Location
- Poland
Results and Publications
| Intention to publish date | 31/01/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study are available from Prof. Małgorzata Paprocka-Borowicz (malgorzata.paprocka-borowicz@umw.edu.pl) upon reasonable request. Raw data (taking into account the anonymity of patients) will become available from the end of the study for 5 years. The research results will be passed on to other researchers in order to compare these results with the results of their own research. |
Editorial Notes
24/01/2025: The total final enrolment was added.
20/02/2023: Trial's existence confirmed by the Institutional Review Board at Wroclaw Medical University.
