Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 24 of 43 for:    "multiple sclerosis" AND "vitamin D"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01728922
Recruitment Status : Completed
First Posted : November 20, 2012
Last Update Posted : May 3, 2017
Sponsor:
Collaborators:
University of Dublin, Trinity College
St Vincent's University Hospital, Ireland
Information provided by (Responsible Party):
Professor Michael Hutchinson, University College Dublin

Brief 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

Condition or disease Intervention/treatment Phase
Clinically Isolated Syndrome Multiple Sclerosis Dietary Supplement: 5000IU vitamin D Dietary Supplement: 10000IU vitamin D Other: Placebo Phase 1 Phase 2

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: double-blind, dose ranging, two doses of vitamin D, randomised parallel groups with placebo arms in clinically isolated syndrome and heathy control participants
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: similar appearance of placebo and active drug
Primary Purpose: Treatment
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.
Actual Study Start Date : November 6, 2012
Actual Primary Completion Date : June 5, 2015
Actual Study Completion Date : June 5, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
Active Comparator: 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.
Dietary Supplement: 5000IU vitamin D
Vigantol Oil
Other Name: Vigantol Oil

Active Comparator: 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.
Dietary Supplement: 10000IU vitamin D
Vigantol Oil
Other Name: Vigantol Oil

Placebo Comparator: CIS - placebo
15 patients will be administered placebo and all outcome measures will be assessed.
Other: Placebo
Placebo Oil
Other Name: Placebo Oil

Active Comparator: CIS - 5,000 IU vitamin D
15 patients will be administered 5,000 IU vitamin D and all outcomes will be assessed.
Dietary Supplement: 5000IU vitamin D
Vigantol Oil
Other Name: Vigantol Oil

Active Comparator: CIS - 10,000 IU vitamin D
15 patients will be administered 10,000 IU of vitamin D and all outcome measures assessed.
Dietary Supplement: 10000IU vitamin D
Vigantol Oil
Other Name: Vigantol Oil

Placebo Comparator: Healthy control - placebo
13 control participants who will be administered placebo. These will be assessed for the primary outcome and safety outcomes only.
Other: Placebo
Placebo Oil
Other Name: Placebo Oil




Primary Outcome Measures :
  1. 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. ]
    A number of measures will be examined in particular IL-10 production and the frequency of Th17 cells.


Secondary Outcome Measures :
  1. The number of new T2 and gadolinium enhancing lesions compared to baseline amongst the study group. [ Time Frame: Baseline and 24 weeks ]
    The MRI out-come measure will assess the a) number of Gadolinium enhancing lesions b) the number of new and enlarging T2 lesions c) the combined unique lesion count (new and enlarging T2 lesions plus Gadolinium enhancing lesions) after 24 weeks of therapy in the three arms, 5000IU, 10,000IU vitamin D and placebo . Mean and median new T2 and gadolinium-enhancing lesions at 24 weeks (end of the trial) will be compared for each treatment allocation group. In addition the mean and median number of new T2 lesions plus gadolinium enhancing lesions in all the CIS patients on vitamin D will be compared to the mean and median in the placebo group.

  2. Relapse occurrence in the CIS patients during 24 weeks of the trial [ Time Frame: At each clinic visit or as the need arises. ]
    Relapse occurrence in the CIS patients during 24 weeks of the trial;(i) annualised relapse rates (ARR), (ii) percentage of patients free from relapses and (iii) time to first relapse will be compared for each treatment allocation group. In addition the same relapse measures will be applied to both vitamin D treated groups combined and compared to those in the placebo group.

  3. 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. ]

Other Outcome Measures:
  1. Serum calcium [ Time Frame: Every 4 weeks for 24 weeks ]
    a measure of calcium homeostasis

  2. Number of participants with adverse events as a measure of safety and tolerability of vitamin D in doses of 5,000IU and 10,000IU daily [ Time Frame: four weekly assessments over 24 weeks ]
  3. serum urea [ Time Frame: 4 weekly over 24 weeks ]
    a measure of renal function

  4. serum creatinine [ Time Frame: 4 weekly over 24 weeks ]
    a measure of renal function

  5. serum 25(OH)D levels [ Time Frame: 4 weekly over 24 weeks ]
    a measure of response to oral dosing and adherence to therapy.

  6. serum parathormone (iPTH) [ Time Frame: 4 weekly over 24 weeks ]
    a measure of parathyroid function



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01728922


Locations
Layout table for location information
Ireland
St Vincent's University Hospital
Dublin, Dublin 4, Ireland
Sponsors and Collaborators
University College Dublin
University of Dublin, Trinity College
St Vincent's University Hospital, Ireland
Investigators
Layout table for investigator information
Principal Investigator: Michael Hutchinson, MB, FRCP St Vincent's University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Professor Michael Hutchinson, Consultant Neurologist, Newman Clinical Research Professor, University College Dublin
ClinicalTrials.gov Identifier: NCT01728922     History of Changes
Other Study ID Numbers: 2012CIS/VD/SVUH
First Posted: November 20, 2012    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all demographic details and outcome measures may be obtained directly from the PI by e-mail

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Professor Michael Hutchinson, University College Dublin:
Clinically isolated syndrome
Multiple sclerosis
Vitamin D
Immune response
CD4 T cell subsets
Cytokine
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Vitamin D
Syndrome
Sclerosis
Disease
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents