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Vitamine D in Multiple Sclerosis (MSVit)

Primary Purpose

Multiple Sclerosis

Status
Unknown status
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Vitamin D
Placebo
Sponsored by
Mazandaran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple sclerosis, Vitamin D, EDSS, ARR

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mazandaran University of medical sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Vitamin D

Placebo

Arm Description

treatment with weekly 50000IU vitamin D

Treatment with placebo

Outcomes

Primary Outcome Measures

Expanded disability state scale score (EDSS)

Secondary Outcome Measures

Annual relapse rate(ARR)

Full Information

First Posted
January 11, 2013
Last Updated
January 11, 2013
Sponsor
Mazandaran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01768039
Brief Title
Vitamine D in Multiple Sclerosis
Acronym
MSVit
Official Title
Randomised Double Blind Placebo-controlled Trial of Vitamine D Supplement in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
October 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mazandaran University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple sclerosis, Vitamin D, EDSS, ARR

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D
Arm Type
Active Comparator
Arm Description
treatment with weekly 50000IU vitamin D
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Treatment with placebo
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Expanded disability state scale score (EDSS)
Time Frame
Changes in EDSS from baseline to 6 months
Secondary Outcome Measure Information:
Title
Annual relapse rate(ARR)
Time Frame
Changes in ARR from baseline to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud Abedini, MD
Phone
01513243158
Email
mahmoudabedini@yahoo.com
Facility Information:
Facility Name
Mazandaran University of medical sciences
City
Sari
State/Province
Mazandaran
Country
Iran, Islamic Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmoud Abedini, MD

12. IPD Sharing Statement

Learn more about this trial

Vitamine D in Multiple Sclerosis

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