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The Effects of Interferon Beta Combined With Vitamin D on Relapsing Remitting Multiple Sclerosis Patients

NCT01005095 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2012-09-05

No results posted yet for this study

Summary

The investigators hypothesize that vitamin D supplementation may ameliorate interferon beta-induced flu-like symptoms, owing to reduced release and activity of the cytokines that are in correlation with this adverse event. Vitamin D supplementation may also positively affect injection site reactions due to its immunomodulatory effects. Vitamin D may also augment the therapeutic efficacy of interferon beta among multiple sclerosis (MS) patients. Vitamin D intake may influence melatonin levels of MS patients as they share the same nuclear receptor.

Conditions

Interventions

DIETARY_SUPPLEMENT

Vitamin D3

Patients will be treated daily with 800 IU of Vitamin D3 by tablets plus a bottle of 75,000 IU vitamin D3 solution every 3 weeks

DIETARY_SUPPLEMENT

Vitamin D3

Patients will receive 800 IU of vitamin D3 by tablets plus a 3 weekly placebo solution

Sponsors & Collaborators

  • Carmel Medical Center

    lead OTHER

Principal Investigators

  • Ariel Miller, Prof · Multiple Sclerosis Center Carmel Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • Israel

Study Locations

More Related Trials

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 NCT01005095 on ClinicalTrials.gov