Vitamine D in Multiple Sclerosis

NCT ID: NCT01768039

Last Updated: 2013-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Vitamin D

treatment with weekly 50000IU vitamin D

Group Type ACTIVE_COMPARATOR

Vitamin D

Intervention Type DRUG

Placebo

Treatment with placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Vitamin D

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mazandaran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud Abedini

associate professor of neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mazandaran University of medical sciences

Sari, Mazandaran, Iran

Site Status

Countries

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Iran

Central Contacts

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Mahmoud Abedini, MD

Role: CONTACT

01513243158

Other Identifiers

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MS-1191

Identifier Type: -

Identifier Source: org_study_id

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