Safety and Immunologic Effect of Low Dose Versus High Dose Vitamin D3 in Multiple Sclerosis - Full Text View

Sponsor:	Johns Hopkins University
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT01024777

Purpose

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.

Condition	Intervention	Phase
Multiple Sclerosis Vitamin D Deficiency	Dietary Supplement: Cholecalciferol	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: carbamoyl phosphate synthetase I deficiency

MedlinePlus related topics: Multiple Sclerosis Vitamin D

Drug Information available for: Cholecalciferol Vitamin D

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

Assess safety of high dose cholecalciferol in patients with multiple sclerosis [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
Assess the effects of cholecalciferol supplementation on serum immune markers in patients with multiple sclerosis [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess clinical effects of cholecalciferol supplementation in patients with multiple sclerosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	March 2010
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: High dose cholecalciferol Patients in the high dose arm will receive 10,000 international units of cholecalciferol daily.	Dietary Supplement: 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
Active Comparator: Low dose cholecalciferol Patients enrolled in the low dose arm will receive up to 1000 international units of cholecalciferol daily.	Dietary Supplement: 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

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01024777

Contacts

Contact: Christopher Eckstein, MD

(410) 502-1937

eckstein@jhmi.edu

Locations

United States, Maryland
Johns Hopkins University	Recruiting
Baltimore, Maryland, United States, 21287
Contact: Christopher Eckstein 410-502-1937 eckstein@jhmi.edu
Principal Investigator: Peter Calabresi, MD
Sub-Investigator: Johns Ratchford, MD
Sub-Investigator: Christopher Eckstein, MD
Sub-Investigator: Shiv Saidha, MBBCH
Sub-Investigator: Daniel Harrison, MD
Sub-Investigator: Scott Newsome, DO

Sponsors and Collaborators

Johns Hopkins University

Investigators

Principal Investigator:	Peter Calabresi, MD	Johns Hopkins University
Principal Investigator:	John Ratchford, MD	Johns Hopkins University

More Information

No publications provided

Responsible Party:	Peter A. Calabresi, MD, Professor of Neurology, Johns Hopkins University, Department of Neurology
ClinicalTrials.gov Identifier:	NCT01024777 History of Changes
Other Study ID Numbers:	NA_00023005
Study First Received:	December 2, 2009
Last Updated:	June 3, 2011
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by Johns Hopkins University:

cholecalciferol
multiple sclerosis
vitamin D
D3

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Vitamin D Deficiency
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Avitaminosis
Deficiency Diseases

Malnutrition
Nutrition Disorders
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on February 09, 2012