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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03385356 |
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Date of registration:
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20/12/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Impact of Vitamin D Supplementation in Patients With Multiple Sclerosis
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Scientific title:
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Impact of Vitamin D Supplementation in Patients With Multiple Sclerosis |
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Date of first enrolment:
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December 19, 2017 |
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Target sample size:
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89 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03385356 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 4
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Countries of recruitment
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Slovenia
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Contacts
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Name:
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Saša Gselman, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Medical Centre Maribor |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Relapsing remitting MS
- Treatment with immunomodulatory drug
- Age 18-60 years and
- EDSS (Expanded Disability Status Scale) score less than 5.
Exclusion Criteria:
- Use of vitamin D supplements in the past 3 months
- Pregnancy, planning pregnancy or nursing
- Relapse of disease and corticosteroids use in past month
- Active inflammation at the start of the study (flu, cystitis etc.)
- Renal disease
- Elevated levels of calcium or parathormone
- Hypersensitivity to vitamin D preparations
- Switching of immunomodulatory drug in past 3 months
- Other autoimmune disease
- History of hyperparathyroidism, liver disease, tuberculosis, sarcoidosis or kidney
stones
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis, Relapsing-Remitting
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Vitamin D Deficiency
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Intervention(s)
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Drug: Vitamin D
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Primary Outcome(s)
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Vitamin D supplementation dose response
[Time Frame: 4 months]
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Secondary ID(s)
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38602SUN17
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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