Overview

This trial is active, not recruiting.

Conditions clinically isolated syndrome, multiple sclerosis
Treatments 5000iu vitamin d, 10000iu vitamin d, placebo
Phase phase 2
Sponsor University College Dublin
Collaborator University of Dublin, Trinity College
Start date November 2012
End date May 2015
Trial size 84 participants
Trial identifier NCT01728922, 2012CIS/VD/SVUH

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
13 healthy controls will be administered 5,000 IU vitamin D. Primary outcome and safety outcome measures will be assessed.
5000iu vitamin d Vigantol Oil
Vigantol Oil
(Active Comparator)
13 healthy controls will be administered 10,000 IU vitamin D. Primary outcome and safety outcome measures will be assessed.
10000iu vitamin d Vigantol Oil
Vigantol Oil
(Placebo Comparator)
15 patients will be administered placebo and all outcome measures will be assessed.
placebo Placebo Oil
Placebo Oil
(Active Comparator)
15 patients will be administered 5,000 IU vitamin D and all outcomes will be assessed.
5000iu vitamin d Vigantol Oil
Vigantol Oil
(Active Comparator)
15 patients will be administered 10,000 IU of vitamin D and all outcome measures assessed.
10000iu vitamin d Vigantol Oil
Vigantol Oil
(Placebo Comparator)
13 control participants who will be administered placebo. These will be assessed for the primary outcome and safety outcomes only.
placebo Placebo Oil
Placebo Oil

Primary Outcomes

Measure
The effects of two doses of vitamin D and placebo therapy on the change in the frequency of CD4 T cell subsets and cytokine responses of PBMC over 24 weeks of therapy from baseline.
time frame: This outcome measure will be assessed at baseline and at 24 weeks.

Secondary Outcomes

Measure
The number of new T2 and gadolinium enhancing lesions compared to baseline amongst the study group.
time frame: Baseline and 24 weeks
Relapse occurrence in the CIS patients during 24 weeks of the trial
time frame: At each clinic visit or as the need arises.
The percentage of CIS patients in each treatment arm free from any evidence of disease activity (No relapses, no new T2 lesions, no gadolinium enhancing lesions).
time frame: At 24 weeks.

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

Inclusion Criteria: To be eligible for inclusion, each subject must meet each of the following criteria at Screening (Visit 1) and must continue to fulfil these criteria at Baseline (Visit 2). - CIS: Patients with a clinically isolated syndrome with onset relapse within the previous three months and two or more than two asymptomatic T2 lesions on MRI brain scan. - Aged 18-55yrs. - Not receiving any disease modifying therapy. Exclusion Criteria: - Patients in whom any disease other than demyelination could explain their signs and symptoms. - Participants with known disease of the parathyroids, a history of vitamin D intolerance, sarcoidosis, a history of hypercalcaemia of any cause. - Participants with a baseline abnormality in serum urea, creatinine, calcium, parathormone. - Participants on thiazide diuretics (hypercalcaemia risk). - Patients with occurrence of a relapse less than six weeks prior to entry to study. - Previous treatment with beta-interferons or glatiramer acetate or steroids in the last three months. - Any previous treatment with mitoxantrone or other immunosuppressant. - Participants already taking supplemental vitamin D.

Additional Information

Official title Dose-related Effects of Vitamin D3 on Immune Responses in Patients With Clinically Isolated Syndrome and Healthy Control Participants. An Exploratory Double Blind Placebo Randomised Controlled Study.
Principal investigator Michael Hutchinson, MB, FRCP
Description Primary endpoint: To determine the effects of vitamin D supplementation at two doses a) 5,000 IU daily b) 10,000 IU daily compared to c) placebo a 24 weeks period on the change from baseline in frequency of CD4 T cell subsets and cytokine responses by peripheral blood mononuclear cells in 1) patients with the clinically isolated syndrome. 2) healthy control participants. Secondary endpoints: 1. To determine whether there is a dose response effect of supplementation using 5,000 IU and 10,000 IU of vitamin D versus placebo over 24 weeks on the change from baseline in the frequency of CD4 T cell subsets and cytokine responses by PBMC in 1) patients with the clinically isolated syndrome (CIS) 2) healthy control participants 2. To establish whether there is a clinical response to vitamin D measured by a) change in the number of T2 lesions and Gadolinium enhancing lesions on MRI scanning at 24 weeks compared to baseline b) reduction in relapses over 24 weeks in treated (both 5,000 IU and 10,000 IU) CIS patients versus CIS patients receiving placebo.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University College Dublin.