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Vitamine D in Multiple Sclerosis (MSVit)

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ClinicalTrials.gov Identifier: NCT01768039
Recruitment Status : Unknown
Verified January 2013 by Mahmoud Abedini, Mazandaran University of Medical Sciences.
Recruitment status was:  Not yet recruiting
First Posted : January 15, 2013
Last Update Posted : January 15, 2013
Information provided by (Responsible Party):
Mahmoud Abedini, Mazandaran University of Medical Sciences

Brief Summary:

Two hundred and forty patients with multiple sclerosis who met the study criteria will be enrolled in this randomized double blind placebo-controlled clinical trial.

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Vitamin D Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomised Double Blind Placebo-controlled Trial of Vitamine D Supplement in Multiple Sclerosis
Study Start Date : March 2013
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Vitamin D
treatment with weekly 50000IU vitamin D
Drug: Vitamin D
Placebo Comparator: Placebo
Treatment with placebo
Drug: Placebo

Primary Outcome Measures :
  1. Expanded disability state scale score (EDSS) [ Time Frame: Changes in EDSS from baseline to 6 months ]

Secondary Outcome Measures :
  1. Annual relapse rate(ARR) [ Time Frame: Changes in ARR from baseline to 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • BMI:18-30kg/m2
  • caucasian race
  • Relapsing remitting multiple sclerosis
  • treatment with interferon beta

Exclusion Criteria:

  • Recent vitamin D supplement therapy
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01768039

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Contact: Mahmoud Abedini, MD 01513243158 mahmoudabedini@yahoo.com

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Iran, Islamic Republic of
Mazandaran University of medical sciences
Sari, Mazandaran, Iran, Islamic Republic of
Principal Investigator: Mahmoud Abedini, MD         
Sponsors and Collaborators
Mazandaran University of Medical Sciences
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Responsible Party: Mahmoud Abedini, associate professor of neurology, Mazandaran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01768039    
Other Study ID Numbers: MS-1191
First Posted: January 15, 2013    Key Record Dates
Last Update Posted: January 15, 2013
Last Verified: January 2013
Keywords provided by Mahmoud Abedini, Mazandaran University of Medical Sciences:
Multiple sclerosis
Vitamin D
Additional relevant MeSH terms:
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Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Vitamin D
Physiological Effects of Drugs
Bone Density Conservation Agents