Abstract Details

Title Safety Profile and Immunologic Effects of High vs. Low-Dose Cholecalciferol in Relapsing-Remitting Multiple Sclerosis: A Randomized Double-Blind Pilot Study

Topic MS and Related Diseases

Presentation(s) S01 - (-)

Poster/Presentation
Number 006

Background Low serum levels of vitamin D have been shown to be associated with an increased incidence of MS and with increased clinico-radiologic disease activity in established disease. This association is thought to be related to immunomodulatory effects of vitamin D.

Objective

Design/Methods This study is a double-blind, single-center, randomized pilot study. Forty participants with a diagnosis of relapsing-remitting MS were randomized to receive 1,000mg calcium plus 10,400IU or 800IU cholecalciferol daily for a period of 6-months. The last participant will complete the 6-month follow-up in February 2013. Clinical assessment and blood sample collection (serum, peripheral blood mononuclear cells and PAXgene tubes) is performed at baseline, 3 and 6-months. Main study inclusion criteria included: screening 25-hydroxyvitamin D level of 20-50 ng/mL, age of 18-55, and no high-dose vitamin D supplementation (>1,000IU/day) in the 3 months prior to enrollment.

Results At baseline, mean age was 40±8.4 years, 70% were female, mean serum 25-hydroxyvitamin D was 27.5±8.6ng/mL, and median EDSS was 3.0 (IQR:2-3.5). Mean end-of-study serum 25-hydroxyvitamin D was 47.3±21.4ng/mL for 30 participants who have completed the study. Two subjects have experienced an MS relapse during the study. To date, adverse effects include: 1 subject developed mild hypercalcemia, 12 patients had an increased random urine calcium/creatinine ratio (?0.21) at the mid and/or end-study visit, 3 subjects discontinued supplementation or withdrew from the study due to gastrointestinal disturbances attributed to the study medication, and 2 subjects withdrew due to perceived side-effects, which were thought to be unrelated to the study. The effects of high vs. low-dose cholecalciferol on cytokines and gene expression will be analyzed.

Conclusions Final safety data and immunologic outcomes will be presented.

Authors/Disclosures
Elias S. Sotirchos, MD (Johns Hopkins University) PRESENTER	Dr. Sotirchos has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. Sotirchos has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Sotirchos has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amgen. Dr. Sotirchos has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Therapeutics. The institution of Dr. Sotirchos has received research support from National Institutes of Health. The institution of Dr. Sotirchos has received research support from National Multiple Sclerosis Society. The institution of Dr. Sotirchos has received research support from Sumaira Foundation. The institution of Dr. Sotirchos has received research support from Genentech. The institution of Dr. Sotirchos has received research support from UCB. The institution of Dr. Sotirchos has received research support from Astoria Biologica. The institution of Dr. Sotirchos has received research support from Ad Scientiam. The institution of Dr. Sotirchos has received research support from Alexion. The institution of Dr. Sotirchos has received research support from Corevitas. Dr. Sotirchos has received personal compensation in the range of $500-$4,999 for serving as a Ad Hoc Reviewer with National Institutes of Health.
Christopher P. Eckstein, MD	The institution of Dr. Eckstein has received research support from Biogen. The institution of Dr. Eckstein has received research support from Genzyme.
Shiv Saidha, MD (Johns Hopkins)	Dr. Saidha has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for ReWind Therapeutics. Dr. Saidha has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Therapeutics. Dr. Saidha has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Saidha has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Clene Pharmaceuticals. Dr. Saidha has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Saidha has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. Saidha has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. Dr. Saidha has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Multiple Sclerosis Journal ETC. Dr. Saidha has stock in June Brain. Dr. Saidha has stock in Lapix Therapeutics. The institution of Dr. Saidha has received research support from Biogen. The institution of Dr. Saidha has received research support from Genentech. The institution of Dr. Saidha has received research support from Novartis. The institution of Dr. Saidha has received research support from Lapix Therapeutics. The institution of Dr. Saidha has received research support from Novartis.
Sonya U. Steele, MD (Johns Hopkins University)	No disclosure on file
Jiwon Oh, MD, FAAN (St Michael's Hospital)	Dr. Oh has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche. The institution of Dr. Oh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen-Idec. Dr. Oh has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMD-Serono. Dr. Oh has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi-Genzyme. Dr. Oh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Oh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly. Dr. Oh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen. Dr. Oh has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Oh has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen-Idec. Dr. Oh has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi-Genzyme. The institution of Dr. Oh has received research support from Biogen-Idec. The institution of Dr. Oh has received research support from Roche.
Scott D. Newsome, DO, FAAN (Johns Hopkins Hospital)	Dr. Newsome has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Newsome has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. Newsome has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Newsome has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bristol Myers Squibb. Dr. Newsome has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Therapeutics. The institution of Dr. Newsome has received research support from Biogen. The institution of Dr. Newsome has received research support from Genentech/Roche. The institution of Dr. Newsome has received research support from Department of Defense. The institution of Dr. Newsome has received research support from Patient Centered Outcomes Research Institute. The institution of Dr. Newsome has received research support from National MS Society. The institution of Dr. Newsome has received research support from The Stiff Person Syndrome Research Foundation. The institution of Dr. Newsome has received research support from Lundbeck. The institution of Dr. Newsome has received research support from Sanofi. Dr. Newsome has received personal compensation in the range of $10,000-$49,999 for serving as a Lead PI for Clinical Trial with Roche.
Bruce Roberts, PhD	No disclosure on file
Ellen M. Mowry, MD, FAAN (Johns Hopkins University)	Dr. Mowry has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BeCareLink, LLC. The institution of Dr. Mowry has received research support from Biogen. The institution of Dr. Mowry has received research support from Genentech. Dr. Mowry has received publishing royalties from a publication relating to health care.
John Ratchford, MD (Genentech)	Dr. Ratchford has received personal compensation for serving as an employee of Genentech. Dr. Ratchford has stock in F. Hoffman La-Roche.
Peter A. Calabresi, MD, FAAN (Johns Hopkins University)	Dr. Calabresi has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Calabresi has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lilly. Dr. Calabresi has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Idorsia. An immediate family member of Dr. Calabresi has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for MyMD. Dr. Calabresi has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Myelin Repair Foundation. The institution of Dr. Calabresi has received research support from Genentech. Dr. Calabresi has received publishing royalties from a publication relating to health care. Dr. Calabresi has received personal compensation in the range of $500-$4,999 for serving as a Study Section Member with NIH. Dr. Calabresi has received personal compensation in the range of $500-$4,999 for serving as a Grant reveiwer with Myelin Repair Foundation. Dr. Calabresi has received personal compensation in the range of $500-$4,999 for serving as a Speaker for CME with NYAS. Dr. Calabresi has received personal compensation in the range of $500-$4,999 for serving as a Speaker with Academic CME.

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