Vitamine D in Multiple Sclerosis (MSVit)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by Mazandaran University of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Mahmoud Abedini, Mazandaran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01768039
First received: January 11, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Mazandaran University of Medical Sciences:

Primary Outcome Measures:
  • Expanded disability state scale score (EDSS) [ Time Frame: Changes in EDSS from baseline to 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Annual relapse rate(ARR) [ Time Frame: Changes in ARR from baseline to 12 months ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01768039

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

Locations
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

No publications provided

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

Keywords provided by Mazandaran University of Medical Sciences:
Multiple sclerosis
Vitamin D
EDSS
ARR

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014