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Vitamine D in Multiple Sclerosis (MSVit)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Mahmoud Abedini, Mazandaran University of Medical Sciences.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Mahmoud Abedini, Mazandaran University of Medical Sciences Identifier:
First received: January 11, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted

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 Intervention Phase
Multiple Sclerosis Drug: Vitamin D Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomised Double Blind Placebo-controlled Trial of Vitamine D Supplement in Multiple Sclerosis

Resource links provided by NLM:

Further study details as provided by Mahmoud Abedini, Mazandaran University of Medical Sciences:

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

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

Estimated Enrollment: 240
Study Start Date: March 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin D
treatment with weekly 50000IU vitamin D
Drug: Vitamin D
Placebo Comparator: Placebo
Treatment with placebo
Drug: Placebo


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01768039

Contact: Mahmoud Abedini, MD 01513243158

Iran, Islamic Republic of
Mazandaran University of medical sciences Not yet recruiting
Sari, Mazandaran, Iran, Islamic Republic of
Principal Investigator: Mahmoud Abedini, MD         
Sponsors and Collaborators
Mazandaran University of Medical Sciences
  More Information

Responsible Party: Mahmoud Abedini, associate professor of neurology, Mazandaran University of Medical Sciences Identifier: NCT01768039     History of Changes
Other Study ID Numbers: MS-1191
Study First Received: January 11, 2013
Last Updated: January 11, 2013

Keywords provided by Mahmoud Abedini, Mazandaran University of Medical Sciences:
Multiple sclerosis
Vitamin D

Additional relevant MeSH terms:
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
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on June 23, 2017