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