Vitamine D in Multiple Sclerosis

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01768039

Acronym

MSVit

Enrollment

240

Registered

2013-01-15

Start date

2013-03-31

Completion date

2014-10-31

Last updated

2013-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis, Vitamin D, EDSS, ARR

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.

Interventions

DRUGVitamin D

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Annual relapse rate(ARR)	Changes in ARR from baseline to 12 months

Countries

Iran

Contacts

Primary ContactMahmoud Abedini, MD

mahmoudabedini@yahoo.com01513243158

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026