PLEASE NOTE: THIS STUDY IS NO LONGER RECRUITING PARTICIPANTS
Summary: Investigators at several centers nationwide are recruiting 172 people with relapsing-remitting MS to compare the effectiveness of the current recommended amount of vitamin D supplementation versus high dose vitamin D supplementation at reducing MS disease activity, when added to standard therapy with glatiramer acetate (Copaxone®, Teva Pharmaceutical Industries). The principal investigator is Ellen Mowry, MD, MCR (Johns Hopkins University, Baltimore) and the study is funded by a research grant from the National MS Society, with partial support from the Society's Greater Delaware Valley Chapter.
Rationale: A number of genetic and environmental factors influence whether a person will get MS. These factors may also impact the severity of the disease. Research is increasingly pointing to a reduced level of vitamin D in the blood as a risk factor for developing MS. In lab mice, vitamin D can reduce the effects of EAE, an MS-like disease, and growing evidence suggests it is time to test whether vitamin D can provide benefits to people who have MS.
Eligibility and Details: Participants should be between the ages of 18 and 50, and diagnosed with relapsing-remitting MS. Participants must be willing to stop taking additional supplemental vitamin D, except as part of a multivitamin, and must be willing to not take cod liver oil. More details on the enrollment criteria are available from the website and contacts below.
Participants will begin standard Copaxone treatment daily and will be randomly assigned to take either 600 IU (the current recommended daily allowance) or 5000 IU of vitamin D. The primary goal of the study is to determine the effects on reducing the proportion of people who experience a relapse. Other outcomes being studied include relapse rate, quality of life, brain tissue volume, disability progression, and excess calcium levels in the blood (a possible side effect of high doses of vitamin D).
Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please see: http://www.clinicaltrials.gov/ct2/show/NCT01490502, or e-mail firstname.lastname@example.org.
Sites are active in the following cities, and more may be added; please refer to the above link to the clinicaltrials.gov listing for the latest information:
New Haven, CT
New York, NY
San Francisco, CA
St. Louis, MO
Stony Brook, NY
Download a brochure that discusses issues to think about when considering enrolling in an MS clinical trial (PDF).
Copaxone is a registered trademark of Teva Pharmaceutical Industries.