Vitamine D in Multiple Sclerosis

Phase 3

• Conditions: Multiple Sclerosis
• Interventions: Drug: Vitamin D; Drug: Placebo

• Registration Number: NCT01768039
• Lead Sponsor: Mazandaran University of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-01
• Study First Submitted: 2013-01-11
• Study First Submitted QC: 2013-01-11
• Last Update Submitted: 2013-01-11
• Study First Posted: 2013-01-15
• Last Update Posted: 2013-01-15
• Study Start: 2013-03
• Primary Completion: 2014-08
• Study Completion: 2014-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D	Vitamin D	treatment with weekly 50000IU vitamin D
Placebo	Placebo	Treatment with placebo

Primary Outcome Measures

Name	Time	Method
Expanded disability state scale score (EDSS)	Changes in EDSS from baseline to 6 months

Secondary Outcome Measures

Name	Time	Method
Annual relapse rate(ARR)	Changes in ARR from baseline to 12 months

Trial Locations

Locations (1)

Mazandaran University of medical sciences; 🇮🇷 Sari, Mazandaran, Iran, Islamic Republic of