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Safety and Immunologic Effect of Low Dose Versus High Dose Vitamin D3 in Multiple Sclerosis

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: NCT01024777
Recruitment Status : Completed
First Posted : December 3, 2009
Last Update Posted : February 6, 2013
Sponsor:
Information provided by (Responsible Party):
Peter A. Calabresi, Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE December 2, 2009
First Posted Date  ICMJE December 3, 2009
Last Update Posted Date February 6, 2013
Study Start Date  ICMJE March 2010
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2010)
  • Assess safety of high dose cholecalciferol in patients with multiple sclerosis [ Time Frame: 3-6 months ]
  • Assess the effects of cholecalciferol supplementation on serum immune markers in patients with multiple sclerosis [ Time Frame: 3-6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 2, 2009)
  • Assess safety of high dose cholecalciferol in patients with relapsing remitting multiple sclerosis [ Time Frame: 3-6 months ]
  • Assess the effects of cholecalciferol supplementation on serum immune markers in patients with relapsing remitting multiple sclerosis [ Time Frame: 3-6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2010)
Assess clinical effects of cholecalciferol supplementation in patients with multiple sclerosis [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2009)
Assess clinical effects of cholecalciferol supplementation in patients with relapsing remitting multiple sclerosis [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Immunologic Effect of Low Dose Versus High Dose Vitamin D3 in Multiple Sclerosis
Official Title  ICMJE A Pilot Study to Assess the Relative Safety and Immunology Effects of Low Dose Versus High Dose Cholecalciferol Supplementation in Patients With Multiple Sclerosis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Multiple Sclerosis
  • Vitamin D Deficiency
Intervention  ICMJE
  • Drug: Cholecalciferol
    Cholecalciferol (Vitamin D3) 10,000 IU in tablet form will be taken once daily for the duration of the trial (6 months)
    Other Name: Vitamin D3
  • Drug: Cholecalciferol
    Cholecalciferol (Vitamin D3) 400 IU in tablet form will be taken once daily for the duration of the trial (6 months)
    Other Name: Vitamin D3
Study Arms  ICMJE
  • Active Comparator: High dose cholecalciferol
    Patients in the high dose arm will receive 10,000 international units of cholecalciferol daily.
    Intervention: Drug: Cholecalciferol
  • Active Comparator: Low dose cholecalciferol
    Patients enrolled in the low dose arm will receive up to 1000 international units of cholecalciferol daily.
    Intervention: Drug: Cholecalciferol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 2, 2009)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01024777
Other Study ID Numbers  ICMJE NA_00023005
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Peter A. Calabresi, Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter Calabresi, MD Johns Hopkins University
Principal Investigator: John Ratchford, MD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP