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临床试验/CTRI/2021/01/030270
CTRI/2021/01/030270已完成不适用

Role of supplement in celiac disease patients with vitamin D deficiencies: a randomization control trial

Jayanta Samanta1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2021年1月18日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
1
主要终点
Follow up Vitamin D levels

研究概览

简要总结

Celiac disease (CD) is an autoimmune enteropathy predominantly manifesting as a gastrointestinal (GI) tract related disease, triggered by gluten ingestion in the diet. Within the spectrum of its malabsorption syndrome, multiple vitamin deficiencies have been reported in the literature. Vitamin D deficiency gained limelight because of the high incidence of low bone mineral density (BMD) (approximately 50%) reported in earlier literature in patients with CD. Vitamin D deficiency was considered to be one of the main causes of low BMD in such patients. Although the calcitriol form of Vitamin D regulates calcium homeostasis and accounts for the bone mineral dynamics, the majority of the data exists on the detection of the 25 (OH) vitamin D in the sera of the CD patients, present up to a tune of 20.3-59%. Hence the exact implication of the measured vitamin D and the active form in CD is dubious. The correlation between the level of vitamin D and BMD too remains unclear. Data on the effects of vitamin D supplementation in CD patients have also yielded mixed responses, with very few of them actually showing a benefit. Vitamin D might be rather a silent bystander in CD patients, with substantial data to prove that GFD alone can improve BMD levels as well as vitamin D levels in CD patients. This raises the question of the need for supplementation of vitamin D in cases of CD with vitamin D deficiency, which might be advocated otherwise in day-to-day practice as a knee-jerk reaction. No robust data or randomized controlled trial has ever looked into this aspect and hence the current study has been planned.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, variable
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
14.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Age ≥ 14 years 2) diagnosed case of celiac disease by IgAtTg levels and duodenal biopsy 3) Serum Vitamin D deficiency.

排除标准

  • Patients not confirmed to have celiac disease as per clinical/histological/ serological workup.
  • Patients not having Vitamin D deficiency at the time of diagnosis.

结局指标

主要结局

Follow up Vitamin D levels

时间窗: At 1 month and 3 months after Vitamin D supplementation

次要结局

  • DEXA scan, iPTH levels and Quality of life assessment(At 3 months and 6 months)

研究者

申办方类型
Other [self]

研究点 (1)

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