MedTrace Logo

Dose-related Effects of Vitamin D3 on Immune Responses in Patients With Clinically Isolated Syndrome

NCT01728922 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2017-05-03

No results posted yet for this study

Summary

The primary purpose of this study is to assess the immune response to vitamin D supplementation at two doses (5,000 IU and 10,000 IU daily) in both healthy controls and patients with clinically isolated syndrome compared to placebo. Secondary endpoints include (1) disease outcome in the clinically isolated syndrome in terms of clinical relapses and evidence of new lesions on MRI (McDonald's MS), 2) Safety of doses used

Conditions

Interventions

DIETARY_SUPPLEMENT

5000IU vitamin D

Vigantol Oil

DIETARY_SUPPLEMENT

10000IU vitamin D

Vigantol Oil

OTHER

Placebo

Placebo Oil

Sponsors & Collaborators

  • University of Dublin, Trinity College

    collaborator OTHER

  • St Vincent's University Hospital, Ireland

    collaborator OTHER

  • University College Dublin

    lead OTHER

Principal Investigators

  • Michael Hutchinson, MB, FRCP · St Vincent's University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-11-06
Primary Completion
2015-06-05
Completion
2016-06-05

Countries

  • Ireland

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 NCT01728922 on ClinicalTrials.gov