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临床试验/NCT03342001
NCT03342001已完成4 期

Assessing Quality of Life Changes Using Calcitonin in Patients With Hypothyroidism on Biochemical Replacement With Levothyroxine

University of Maryland, Baltimore1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2018年6月18日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
11
试验地点
1
主要终点
Modified City of Hope Quality of Life Questionnaire for Patients With Thyroid Disease

研究概览

简要总结

Some people with hypothyroidism have persistent symptoms despite adequate treatment with thyroid hormones. We are testing whether giving calcitonin to such people will improve their quality of life.

详细描述

It is known that a proportion of patients with hypothyroidism despite serum TSH levels being within the normal reference range, may continue to express symptoms of hypothyroidism. Common symptoms include fatigue, muscle pain, weight gain, and mood changes. Saravanan et al. reported in a large community-based survey that patients on levothyroxine even with a normal TSH showed significant impairment in psychological well-being compared with age- and sex-matched controls. These patients are challenging to manage and are often unhappy with they care.

Established treatment of hypothyroidism is levothyroxine. Thyroid follicular cells synthesize and secrete thyroxine and triiodothyronine. However, even when people are receiving adequate levothyroxine replacement therapy, their quality of life may not improve. Calcitonin (CT) is also produced by the thyroid gland, parafollicular cells. Their levels are not tested in hypothyroidism because the exact role of calcitonin in human health and disease is not fully known. CT has long been thought to play an important role in bone and mineral homeostasis, particularly with respect to its ability to regulate calcium metabolism. CT has been found in fish, reptiles, birds, and mammals. Salmon-derived CT is 50-100 times more potent than human CT. Hence, salmon CT (sCT) has been used for medicinal purposes.

There is a need for further research in order to understand the nature of persisting symptoms in patients on T4 monotherapy despite a serum TSH within the reference range. Calcitonin has been shown to alleviate pain in patients with bone or mineral disorders. To date, the use of calcitonin for relief of hypothyroid symptoms has not been studied.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 88 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Normal TSH on levothyroxine therapy

排除标准

  • pregnant or 6 months post partum
  • Current or previous thyroid cancer
  • Congenital hypothyroidism
  • any tobacco use
  • prescribed proton pump inhibitors
  • prescribed steroids
  • taking armour thyroid, naturethroid, or any dessicated thyroid hormone
  • Unstable medical conditions (CKD, Cirrhosis etc)
  • pituitary disease

研究组 & 干预措施

Treatment group, open label

Experimental

calcitonin nasal spray, 200 mcg daily

干预措施: Calcitonin (Drug)

结局指标

主要结局

Modified City of Hope Quality of Life Questionnaire for Patients With Thyroid Disease

时间窗: 6 weeks

questionnaire to assess quality of life, 40 questions, 1-10 scale with 10 indicating more severe symptoms. Total 400 points, primary assessment was change in score after 6 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

Kashif Munir

MD

University of Maryland, Baltimore

研究点 (1)

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