Back to resultsSafety and Immunologic Effect of Low Dose Versus High Dose Vitamin D3 in Multiple Sclerosis
Primary Purpose
Multiple Sclerosis, Vitamin D Deficiency
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cholecalciferol
Cholecalciferol
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring cholecalciferol, multiple sclerosis, vitamin D, D3
Eligibility Criteria
Inclusion Criteria:
- Between ages of 18-55 years (inclusive)
- Serum 25(OH) vitamin D levels between 20-50 ng/mL and a candidate for vitamin D supplementation
- Patients with or without immunomodulatory therapy for RRMS
- Diagnosis of multiple sclerosis
Exclusion Criteria:
- Serum 25(OH) vitamin D deficient level < 20 ng/mL
- High dose vitamin D supplementation in the past 3 months
- Pregnancy
- History of tuberculosis, hyperparathyroidism, sarcoidosis or kidney stones
- Baseline serum creatinine above 1.5
- Hypersensitivity to vitamin D preparations
- Milk allergy
- Unable to consent
Sites / Locations
- Johns Hopkins University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
High dose cholecalciferol
Low dose cholecalciferol
Arm Description
Patients in the high dose arm will receive 10,000 international units of cholecalciferol daily.
Patients enrolled in the low dose arm will receive up to 1000 international units of cholecalciferol daily.
Outcomes
Primary Outcome Measures
Assess safety of high dose cholecalciferol in patients with multiple sclerosis
Assess the effects of cholecalciferol supplementation on serum immune markers in patients with multiple sclerosis
Secondary Outcome Measures
Assess clinical effects of cholecalciferol supplementation in patients with multiple sclerosis
Full Information
NCT ID
NCT01024777
First Posted
December 2, 2009
Last Updated
February 5, 2013
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT01024777
Brief Title
Safety and Immunologic Effect of Low Dose Versus High Dose Vitamin D3 in Multiple Sclerosis
Official Title
A Pilot Study to Assess the Relative Safety and Immunology Effects of Low Dose Versus High Dose Cholecalciferol Supplementation in Patients With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine the safety and the immunologic effects of supplementation with low-dose and high-dose cholecalciferol (vitamin D3) in patients with multiple sclerosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Vitamin D Deficiency
Keywords
cholecalciferol, multiple sclerosis, vitamin D, D3
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High dose cholecalciferol
Arm Type
Active Comparator
Arm Description
Patients in the high dose arm will receive 10,000 international units of cholecalciferol daily.
Arm Title
Low dose cholecalciferol
Arm Type
Active Comparator
Arm Description
Patients enrolled in the low dose arm will receive up to 1000 international units of cholecalciferol daily.
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
Vitamin D3
Intervention Description
Cholecalciferol (Vitamin D3) 10,000 IU in tablet form will be taken once daily for the duration of the trial (6 months)
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
Vitamin D3
Intervention Description
Cholecalciferol (Vitamin D3) 400 IU in tablet form will be taken once daily for the duration of the trial (6 months)
Primary Outcome Measure Information:
Title
Assess safety of high dose cholecalciferol in patients with multiple sclerosis
Time Frame
3-6 months
Title
Assess the effects of cholecalciferol supplementation on serum immune markers in patients with multiple sclerosis
Time Frame
3-6 months
Secondary Outcome Measure Information:
Title
Assess clinical effects of cholecalciferol supplementation in patients with multiple sclerosis
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Between ages of 18-55 years (inclusive)
Serum 25(OH) vitamin D levels between 20-50 ng/mL and a candidate for vitamin D supplementation
Patients with or without immunomodulatory therapy for RRMS
Diagnosis of multiple sclerosis
Exclusion Criteria:
Serum 25(OH) vitamin D deficient level < 20 ng/mL
High dose vitamin D supplementation in the past 3 months
Pregnancy
History of tuberculosis, hyperparathyroidism, sarcoidosis or kidney stones
Baseline serum creatinine above 1.5
Hypersensitivity to vitamin D preparations
Milk allergy
Unable to consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Calabresi, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Ratchford, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Immunologic Effect of Low Dose Versus High Dose Vitamin D3 in Multiple Sclerosis
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