Vitamine D in Multiple Sclerosis (MSVit)

Randomised Double Blind Placebo-controlled Trial of Vitamine D Supplement in Multiple Sclerosis

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.

Study Overview

• Status: Unknown
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: Placebo; Drug: Vitamin D

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Mazandaran
    • Sari, Mazandaran, Iran, Islamic Republic of
      • Mazandaran University of medical sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Expanded disability state scale score (EDSS)	Changes in EDSS from baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Annual relapse rate(ARR)	Changes in ARR from baseline to 12 months

Collaborators and Investigators

• Sponsor: Mazandaran University of Medical Sciences

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Anticipated): August 1, 2014
• Study Completion (Anticipated): October 1, 2014

Study Registration Dates

• First Submitted: January 11, 2013
• First Submitted That Met QC Criteria: January 11, 2013
• First Posted (Estimate): January 15, 2013

Study Record Updates

• Last Update Posted (Estimate): January 15, 2013
• Last Update Submitted That Met QC Criteria: January 11, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Vitamin D; Multiple sclerosis; EDSS; ARR
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: MS-1191

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No