Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
240 participants
INTERVENTIONAL
2013-03-31
2014-10-31
Brief Summary
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They will randomly assigned to placebo or vitamin D treatment group. The total time of study is 52 weeks and the vitamin D group will be treated by weekly 50000 International unit(IU) vitamin D, while the other group will receive weekly placebo. The annual relapse rate and EDSS will be compared at baseline, month 6 and 12.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Vitamin D
treatment with weekly 50000IU vitamin D
Vitamin D
Placebo
Treatment with placebo
Placebo
Interventions
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Vitamin D
Placebo
Eligibility Criteria
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Inclusion Criteria
* caucasian race
* Relapsing remitting multiple sclerosis
* treatment with interferon beta
Exclusion Criteria
* Restricted fat diet
* nephrolithiasis in recent 5 years
* Past history of hyperparathyroidism, sarcoidosis, cancer
* Past history of hepatic disease
* Past history of gastrointestinal disease
* Past history of mycobacterial infection
* Past history of hypercalcemia and hypercalciuria
* serum creatinine\>1.5
* Smoking, drug abuse and corticosteroid therapy in recent year
* treatment with thiazides or other drugs that inhibit vitamin D absorption
* Disease attack in recent 2 months
* Serum Ca\>2.6mm0l/L
* Serum 25(OH)D\>85mmol/L
* hypersensitivity to cholecalciferol
* Past history of heart disease
* Major depression
* Uncontrolled hypertension (BP\>180/110)
* Immunosuppressive therapy
18 Years
50 Years
ALL
No
Sponsors
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Mazandaran University of Medical Sciences
OTHER
Responsible Party
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Mahmoud Abedini
associate professor of neurology
Locations
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Mazandaran University of medical sciences
Sari, Mazandaran, Iran
Countries
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Central Contacts
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Other Identifiers
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MS-1191
Identifier Type: -
Identifier Source: org_study_id
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