Viewing Study NCT03342001



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Study NCT ID: NCT03342001
Status: COMPLETED
Last Update Posted: 2022-02-21
First Post: 2017-11-09

Brief Title: Hypothyroidism Treated With Calcitonin
Sponsor: University of Maryland Baltimore
Organization: University of Maryland Baltimore

Study Overview

Official Title: Assessing Quality of Life Changes Using Calcitonin in Patients With Hypothyroidism on Biochemical Replacement With Levothyroxine
Status: COMPLETED
Status Verified Date: 2022-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None