Relapsing Remitting Multiple Sclerosis Clinical Trial
Official title:
Isfahan University of Medical Sciences
This study aimed to evaluate oral and injectable routes in treatment of hypovitaminosis D in multiple sclerosis (MS) patients. The investigators aimed to assess the efficacy of each method, using the same Mega dose of 600 000 IU D3, in achieving normal serum 25(OH)D level, the durability of the response, the practicality and the possible toxicity.
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.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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