Randomised Double Blind Placebo-controlled Trial of Vitamine D Supplement in Multiple Sclerosis
Overview
- Phase
- Phase 3
- Intervention
- Vitamin D
- Conditions
- Multiple Sclerosis
- Sponsor
- Mazandaran University of Medical Sciences
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Expanded disability state scale score (EDSS)
- Last Updated
- 13 years ago
Overview
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.
Investigators
Mahmoud Abedini
associate professor of neurology
Mazandaran University of Medical Sciences
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
Arms & Interventions
Vitamin D
treatment with weekly 50000IU vitamin D
Intervention: Vitamin D
Placebo
Treatment with placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Expanded disability state scale score (EDSS)
Time Frame: Changes in EDSS from baseline to 6 months
Secondary Outcomes
- Annual relapse rate(ARR)(Changes in ARR from baseline to 12 months)