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Role of Vitamin D in Reducing the Relapse Rate in Patients With Multiple Sclerosis

NCT01753375 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2012-12-20

No results posted yet for this study

Summary

Vitamin D3 supplementation reduces the incidence of multiple sclerosis.Although clinical cross-sectional studies have demonstrated vitamin D3 as a positive mediator in preventing relapses and disease progression, prospective randomized control trials are nevertheless necessary to confirm these statements and to determine the most efficacious, safe, and the minimum required doses. This hypothesis is going to be tested through a randomized triple blinded controlled trial in which after randomization, one group of patients will receive vitamin D and second group will receive placebo. Both groups are going to be followed in a similar way over a period of one year with follow ups at 4, 8 and 12 months. Vitamin D levels is going to be performed at 0,4, 12 month interval. MRI is going to be done at the beginning and end of trial.The number of relapses and the physical disability will be calculated through the Expanded disability status scale (EDSS).

Conditions

Interventions

DIETARY_SUPPLEMENT

Vitamin D3

Vitamin D3 given as 50000 IU orally on weekly basis

DIETARY_SUPPLEMENT

Placebo

Placebo to be given orally on weekly basis

Sponsors & Collaborators

  • AlJohara M AlQuaiz, M.D.

    lead OTHER

Principal Investigators

  • AlJohara M AlQuaiz, M.D · King Saud University- Medical college

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-07-31
Completion
2014-10-31

Countries

  • Saudi Arabia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01753375 on ClinicalTrials.gov