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临床试验/CTRI/2024/04/065960
CTRI/2024/04/065960招募中4 期

A Randomized Control Trial of Efficacy and Safety of Daily Versus Weekly Levothyroxine T4 in Hypothyroidism

All India Institute of Medical Sciences Jodhpur1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2024年4月29日最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
56
试验地点
1
主要终点
1. To compare the change in thyroid hormone (T3, T4, TSH) levels between two groups

研究概览

简要总结

Hypothyroidism is one of the most common endocrine disorders. It is found in about 6 % to 17 % of the normal population. It is more commonly seen in females and elderly. The severity of signs, symptoms and complications depends upon degree and time of untreated thyroid failure. Thyroxine also known as Levothyroxine (T4) is derived from thyroid gland itself. Although liothyronine (T3) is derived from T4 by deiodination. Various adverse effects has been noted in patients with hypothyroidism leading to poor Quality of life (QOL). Majority of the hypothyroid patients are seen with mood and cognitive symptoms. In the last few years, weekly T4 has been tested to replace daily T4 regimen because of non-compliance with the patients to weekly T4 regimen (5,6). The major reasons for non-compliance were fasting state before taking the medication early morning, not able to have other drugs or food products containing ferrous sulphate, calcium carbonates or bile acid sequestrants to prevent the interference with the absorption of levothyroxine. It was seen that non-compliance could also lead to metabolic disturbances as well. Because of all these factors affecting daily activities further leading to poor quality of life has led to the investigation of new therapeutic alternatives including weekly high dose of levothyroxine or intermittent T4 dosing further leading to better compliance in patients. Therefore, this study is planned to explore the efficacy and safety of weekly T4 dosing to daily T4 dosing by measuring the level of TSH and seeing the effect on quality of life using SF-36 scale scoring .

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1.Known case of Primary Hypothyroidism 2.Patients willing to give written informed consent.

排除标准

  • 1.Pregnancy and lactating women 2.Patients requiring Levothyroxine dose more than 150 mcg or less than 25 mcg 3.Critical care illness requiring hospitalization in ICU 4.Known cases of pituitary disorders 5.Women currently on Oral Contraceptives Pills or planning to take OCPs 6.Chronic Kidney disease patients with serum creatinine more than 1.8 7.Known cases of nephrotic syndrome 8.All patients diagnosed with Rheumatoid Arthritis 9.Patients with TSH more than 20 milli international unit per liter.

结局指标

主要结局

1. To compare the change in thyroid hormone (T3, T4, TSH) levels between two groups

时间窗: Baseline and 12 weeks

次要结局

  • To compare the mean change in Quality-of-Life scores (SF-36 scaling tool) from baseline to 12 weeks.(Baseline and 12 weeks)
  • To compare the laboratory parameters namely LDL, hsCRP, CBC, Urinary protein and NT-pro BNP in two study groups.(Baseline and 12 weeks)
  • To compare the adverse events between two treatment groups(Baseline and 12 weeks)

研究者

发起方
All India Institute of Medical Sciences Jodhpur
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Surjit Singh

Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur

研究点 (1)

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