Vitamine D in Multiple Sclerosis

• Status: Unknown status
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mazandaran University of Medical Sciences
• Treatments: Ergocalciferols; Vitamin D; Vitamins

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