Relapsing Remitting Multiple Sclerosis Dietary Supplement: Vitamin D3 Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Open LabelPrimary Purpose: Treatment Isfahan University of Medical Sciences Genetics Home Reference related topics: Drug Information available for: Serum concentration of 25(OH)D [ Time Frame: Two Weeks ] November 2015 (Final data collection date for primary outcome measure) Experimental: MS patients injectable Vitamin D3 Experimental: MS patients orally Vitamin D3 Active Comparator: Healthy groups Injectable Vitamin D3 Active Comparator: Healthy groups Vitamin D3 orally Ultraviolet sunlight is too low to produce adequate amounts of vitamin D3, and vitamin D insufficiency lasting 4 to 6 months of the year at latitudes of ≥42° is common in individuals with low vitamin D intake. Vitamin D has strong immunoregulatory effects, and vitamin D supplementation prevents experimental autoimmune encephalomyelitis (EAE), an autoimmune disease in animals that is used as a model of MS.
Recently, emerging data from epidemiologic studies suggest that vitamin D may play an important role in the progression of the development of MS. A longitudinal study in pediatric MS showed a 34% lower risk of relapse for every 10 ng/ml higher 25-hydroxyvitamin D level. A similar magnitude of reduced relapse risk was later reported in an adult MS cohort. Higher vitamin D levels have also been shown to be associated with less subsequent inflammatory MS activity on brain magnetic resonance imaging (MRI). Finally, studies have demonstrated that patients have lower vitamin D levels during MS relapses. Ages Eligible for Study: 23 Years to 59 Years (Adult) Sexes Eligible for Study: with serum 25(OH)D3 concentration ≤ 20 ng/ml hypercalcaemia, primary hyperparathyroidism, Paget disease, thyrotoxicosis, pregnancy, active malignancy, hypercalciuria, history of liver disease, renal insufficiency, clinically apparent malabsorption syndrome, using drugs containing vitamin D products, calcium, estrogen and drugs known to affect vitamin D metabolism (anticonvulsants, glucocorticoids) or receiving any form of supplements containing vitamin D during last 6 months.
Participants with serum 25(OH)D concentration≥ 20 ng/ml Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies. Please refer to this study by its ClinicalTrials.gov identifier: NCT02696590 Isfahan, Iran, Islamic Republic of, 81745319 Isfahan MS Society, Isfahan University of Medical Sciences, Isfahan, Iran Leila Dehghani, assistant prof, Isfahan University of Medical Sciences Other Study ID Numbers: Plan to Share IPD: Additional relevant MeSH terms: Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Physiological Effects of Drugs Bone Density Conservation AgentsSkip to main page content Innovations in Care Delivery
Neurology: Neuroimmunology & Neuroinflammation Diet and Hormonal Factors in Multiple Sclerosis High-dose vitamin D supplementation reduces IL-17-producing CD4+ T-cells and effector-memory CD4+ T-cells in multiple sclerosis 1Baltimore MD United States 2Mobile AL United States 3Johns Hopkins University Baltimore MD United States 4Johns Hopkins University Baltimore MD United States To determine the effect of cholecalciferol supplementation on cytokine production and memory phenotype of CD4+ T-cells in multiple sclerosis (MS) patients. Vitamin D deficiency has been linked to increased risk for developing MS, as well as increased disease activity in established MS. Ex-vivo studies of lymphocytes from vitamin D supplemented MS patients are scarce, although it is a potent immunomodulator Peripheral blood mononuclear cells (PBMCs) were isolated from blood collected at baseline and 6 months in a randomized, double-blind trial of cholecalciferol supplementation in 32 MS patients (15 received high-dose (10,400 IU/day) and 17 low-dose (800 IU/day)
After thawing, PBMCs were stimulated with anti-CD3/CD28 coated beads for 5 days, followed by PMA/Ionomycin for 4 hours to stimulate cytokine production. Immuno-staining was performed for cytokine and memory markers by flow-cytometry. Baseline demographic and immunological parameters were similar between the two groups. The high-dose group had a greater rise in serum 25-hydroxyvitamin D vs. baseline (33.67 vs 5.35 ng/mL, p<0.0001) at the end of the study. There was a decrease in the percentage of IL17+ CD4+ cells in the high-dose group (-3.27[percnt], p=0.027); no change was seen in the low-dose groupThe percentage of T-effector memory (Tem) cells decreased in the high-dose group (-10.4[percnt], p=0.013) but not in the low-dose group (-0.7[percnt], p=0.882). Reduced IL-17 production occurred primarily when the increase in serum 25-hydroxyvitamin D levels was above 20 ng/ml (-1.9[percnt] per 10 ng/ml increase, p=0.007). was noted between the decrease in Tem cells and IL-17+ CD4+ cells (Spearman's rho=0.672, p<0.001).
High-dose vitamin D supplementation reduced IL-17 producing CD4+ T-cells and CD4+ Tem cells in MS, an effect primarily observed in those with substantial increases in 25-hydroxyvitamin D levels. NMSS FP-1787-01 to P.B. Disclosure: Dr. Bhargava has nothing to disclose. Dr. Sotirchos has nothing to disclose. Dr. Eckstein has received personal compensation for activities with Biogen Idec, Bayer Pharmaceuticals, and Pfizer Inc. Dr. Ntranos has nothing to disclose. Dr. Mowry has received research support from Teva Neuroscience. Dr. Calabresi has received personal compensation for activities with Abbott, Vaccinex, and Vertex. Dr. Calabresi has received research support from Novartis and Biogen Idec. Thursday, April 23 2015, 1:00 pm-2:45 pm Email this article to a colleague Alert me when this article is cited Alert me if a correction is posted Alert me when eletters are published Add to My Articles & Searches Download to citation manager