Impact of Vitamin D Supplementation on Thyroid Function in Subclinical Autoimmune Hypothyroidism - A Randomized Double Blind Placebo Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Criteria based on thyroid function
研究概览
简要总结
This is a randomized placebo controlled double blinded trial to ascertain the beneficial effects of vitamin D in patients of subclinical hypothyroid disease due to autoimmune thyroiditis as validated by anti thyroid peroxidase and or anti thyroglobulin positivity. although vitamin D has been established as having a proven immunomodulatory function in several clinical and pre clinical studies, its role in ameliorating the pathophysiology of autoimmunity in Hashimoto’s thyroiditis has not been amply studied in clinical trials. There are few pre clinical trials to prove that vitamin D can actually suppress the autoimmune response of B and T cells and inflammatory markers, thereby arresting autoimmune thyroid destruction in vitro. Few studies outside India, in Serbia, Iran have found a positive correlation between regression of autoimmune thyroiditis and Vitamin D therapy in human clinical trials. However such randomized placebo controlled human studies in Indian subcontinent is lacking distinctly, despite the known fact that both vitamin D deficiency and autoimmune Hashimoto’s thyroiditis are both rampantly existent diseases in Indian population. This study aims to explore this as yet unproven prospect especially in the Indian context by supplementing 60000 units of vitamin D to subclinical subjects of autoimmune hypothyroidism for a period of 6 months and the outcome is expected to demonstrate a clear benefit of this wonder vitamin in thyroid autoimmune disorders. A total of 140 subjects will be enrolled in the study and, after measuring baseline variables, given either placebo or 60000 units of vitamin D sachet every week for 2 months followed by every month for total 6 months followed by repeitition of same variables at follow up to ascertain any change. All data will be recorded and standard statistical methods applied to obtain results and final conclusion will be inferred.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
入选标准
- •Age more than 18 yrs Gender both male and female Positive anti TPO antibody more than 34 International Units per litre as per our hospital laboratory normal upper limit AND OR Positive anti TG more than 20 International Units per litre as per our laboratory normal upper limit for anti TPO negative cases Normal serum free T4 more than 1.9 nanogram per decilitre as per our laboratory normal upper limit.
排除标准
- •Diseases and drugs interfering with vitamin D metabolism like CKD Liver diseases chronic granulomatous diseases like TB sarcoidosis Drugs including phenytoin phenobarbitone valproic acid cholestyramin rifampin orlistat corticosteroid or others Any chronic medications that might interfere with thyroid hormone metabolism Pregnant and lactating women Those who received Vitamin D and calcium in the last 6 months.
结局指标
主要结局
Criteria based on thyroid function
时间窗: 1 year
Responders will be arbitrarily defined as at least 25 percent or greater reduction in serum TSH levels in mili International Units per litre from baseline value in the Intervention group AND OR
时间窗: 1 year
25 percent or greater reduction in serum anti TPO antibody titers in International Units per litre from baseline in the Intervention group
时间窗: 1 year
次要结局
- Criteria of sonographic response is arbitrarily defined as reduction in gland size by 25 percent from baseline OR(Any change in echogenicity of the whole gland or reduction in number or size of nodules by 25 percent from baseline)