Vitamine D in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— MSVit  

Official title:

Randomised Double Blind Placebo-controlled Trial of Vitamine D Supplement in Multiple Sclerosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01768039
• Other study ID #: MS-1191
• Status: Not yet recruiting
• Phase: Phase 3
• First received: January 11, 2013
• Last updated: January 11, 2013
• Start date: March 2013
• Est. completion date: October 2014

Study information

• Verified date: January 2013
• Source: Mazandaran University of Medical Sciences
• Contact: Mahmoud Abedini, MD
• Phone: 01513243158
• Email: mahmoudabedini[@]yahoo.com
• Is FDA regulated: No
• Health authority: Iran: Mazandaran University of medical sciences
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: October 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Vitamin D

• Placebo

Locations

Country	Name	City	State
Iran, Islamic Republic of	Mazandaran University of medical sciences	Sari	Mazandaran

Sponsors (1)

Lead Sponsor	Collaborator
Mazandaran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expanded disability state scale score (EDSS)		Changes in EDSS from baseline to 6 months	No
Secondary	Annual relapse rate(ARR)		Changes in ARR from baseline to 12 months	No