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临床试验/NCT02696590
NCT02696590已完成不适用

Isfahan University of Medical Sciences

Isfahan University of Medical Sciences2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
2
主要终点
Serum concentration of 25(OH)D

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
23 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • with serum 25(OH)D3 concentration ≤ 20 ng/ml

排除标准

  • 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

结局指标

主要结局

Serum concentration of 25(OH)D

时间窗: Two Weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Leila Dehghani

assistant prof

Isfahan University of Medical Sciences

研究点 (2)

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