Role of Vitamin D in Reducing the Relapse Rate in Patients With Multiple Sclerosis
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Cholecalciferol
Vitamin D receptor agonist
Placebo or sham
- Placebo
What it measured
Main measures
Relapse rate in patients with Multiple Sclerosis
12 months
Relapses
Other measures (1)
Improvement in the expanded disability status scores after receiving vitamin D3
12 months
Disability progression
Who could take part
MS (type not specified) · 18 to 55
Inclusion Criteria: * Age between 18-55 years * Confirmed Multiple Sclerosis diagnosis according to McDonald criteria * Stable neurological functioning for at least one month prior to study entry * Expanded Disability Scale score (EDSS) less than \<_4.0 * Must have had one clinical attack in past two years and at least one new silent T2 or gadolinium-enhancing lesion on MRI within the past one year. * Willing to participate for the entire 52-week period Exclusion Criteria: * pregnant or nursing. * Connective tissue disease (SLE, Sjogren's disease) * Endocrine disease (hyperthyroidism, hyperparathyroidism) * Any medical condition predisposing to hypercalcaemia, nephrolithiasis or renal insufficiency
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Vitamin D3 supplementation reduces the incidence of multiple sclerosis.Although clinical cross-sectional studies have demonstrated vitamin D3 as a positive mediator in preventing relapses and disease progression, prospective randomized control trials are nevertheless necessary to confirm these statements and to determine the most efficacious, safe, and the minimum required doses. This hypothesis is going to be tested through a randomized triple blinded controlled trial in which after randomization, one group of patients will receive vitamin D and second group will receive placebo. Both groups are going to be followed in a similar way over a period of one year with follow ups at 4, 8 and 12 months. Vitamin D levels is going to be performed at 0,4, 12 month interval. MRI is going to be done at the beginning and end of trial.The number of relapses and the physical disability will be calculated through the Expanded disability status scale (EDSS).
Papers
Background
Cantorna MT, Hayes CE, DeLuca HF. 1,25-Dihydroxyvitamin D3 reversibly blocks the progression of relapsing encephalomyelitis, a model of multiple sclerosis. Proc Natl Acad Sci U S A. 1996 Jul 23;93(15):7861-4. doi: 10.1073/pnas.93.15.7861.Background
Hayes CE. Vitamin D: a natural inhibitor of multiple sclerosis. Proc Nutr Soc. 2000 Nov;59(4):531-5. doi: 10.1017/s0029665100000768.Background
Munger KL, Zhang SM, O'Reilly E, Hernan MA, Olek MJ, Willett WC, Ascherio A. Vitamin D intake and incidence of multiple sclerosis. Neurology. 2004 Jan 13;62(1):60-5. doi: 10.1212/01.wnl.0000101723.79681.38.Background
Kimball SM, Ursell MR, O'Connor P, Vieth R. Safety of vitamin D3 in adults with multiple sclerosis. Am J Clin Nutr. 2007 Sep;86(3):645-51. doi: 10.1093/ajcn/86.3.645.Background
Shaygannejad V, Janghorbani M, Ashtari F, Dehghan H. Effects of adjunct low-dose vitamin d on relapsing-remitting multiple sclerosis progression: preliminary findings of a randomized placebo-controlled trial. Mult Scler Int. 2012;2012:452541. doi: 10.1155/2012/452541. Epub 2012 Apr 11.Background
Jagannath VA, Fedorowicz Z, Asokan GV, Robak EW, Whamond L. Vitamin D for the management of multiple sclerosis. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD008422. doi: 10.1002/14651858.CD008422.pub2.Background
Burton JM, Kimball S, Vieth R, Bar-Or A, Dosch HM, Cheung R, Gagne D, D'Souza C, Ursell M, O'Connor P. A phase I/II dose-escalation trial of vitamin D3 and calcium in multiple sclerosis. Neurology. 2010 Jun 8;74(23):1852-9. doi: 10.1212/WNL.0b013e3181e1cec2. Epub 2010 Apr 28.
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History
Started
Jan 2013
Main results due
Jul 2014
Finished
Oct 2014
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