Vitamine D in Multiple Sclerosis (MSVit)

Mazandaran University of Medical Sciences

Status and phase: Unknown; Phase 3

Conditions: Multiple Sclerosis

Treatments: Drug: Placebo; Drug: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT01768039

MS-1191

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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240 participants in 2 patient groups, including a placebo group

Vitamin D

Active Comparator group

Description:

treatment with weekly 50000IU vitamin D

Treatment:

Drug: Vitamin D

Placebo

Placebo Comparator group

Description:

Treatment with placebo

Treatment:

Drug: Placebo