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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-06

Study Completion Date

2016-06-05

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Clinically Isolated Syndrome Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

double-blind, dose ranging, two doses of vitamin D, randomised parallel groups with placebo arms in clinically isolated syndrome and heathy control participants

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

similar appearance of placebo and active drug

Study Groups

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Healthy control - 5,000 IU vitamin D

13 healthy controls will be administered 5,000 IU vitamin D. Primary outcome and safety outcome measures will be assessed.

Group Type ACTIVE_COMPARATOR

5000IU vitamin D

Intervention Type DIETARY_SUPPLEMENT

Vigantol Oil

Healthy control - 10,000 IU vitamin D

13 healthy controls will be administered 10,000 IU vitamin D. Primary outcome and safety outcome measures will be assessed.

Group Type ACTIVE_COMPARATOR

10000IU vitamin D

Intervention Type DIETARY_SUPPLEMENT

Vigantol Oil

CIS - placebo

15 patients will be administered placebo and all outcome measures will be assessed.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo Oil

CIS - 5,000 IU vitamin D

15 patients will be administered 5,000 IU vitamin D and all outcomes will be assessed.

Group Type ACTIVE_COMPARATOR

5000IU vitamin D

Intervention Type DIETARY_SUPPLEMENT

Vigantol Oil

CIS - 10,000 IU vitamin D

15 patients will be administered 10,000 IU of vitamin D and all outcome measures assessed.

Group Type ACTIVE_COMPARATOR

10000IU vitamin D

Intervention Type DIETARY_SUPPLEMENT

Vigantol Oil

Healthy control - placebo

13 control participants who will be administered placebo. These will be assessed for the primary outcome and safety outcomes only.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo Oil

Interventions

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5000IU vitamin D

Vigantol Oil

Intervention Type DIETARY_SUPPLEMENT

10000IU vitamin D

Vigantol Oil

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo Oil

Intervention Type OTHER

Other Intervention Names

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Vigantol Oil Vigantol Oil Placebo Oil

Eligibility Criteria

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Inclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes