Hypothyroidism Treated With Calcitonin
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|ClinicalTrials.gov Identifier: NCT03342001|
Recruitment Status : Completed
First Posted : November 14, 2017
Last Update Posted : August 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hypothyroidism||Drug: Calcitonin||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessing Quality of Life Changes Using Calcitonin in Patients With Hypothyroidism on Biochemical Replacement With Levothyroxine|
|Actual Study Start Date :||June 18, 2018|
|Actual Primary Completion Date :||June 30, 2019|
|Actual Study Completion Date :||August 14, 2019|
Experimental: Treatment group, open label
calcitonin nasal spray, 200 mcg daily
calcitonin nasal spray
Other Name: Miacalcin
- Modified City of Hope Quality of Life Questionnaire for patients with thyroid disease [ Time Frame: 6 weeks ]questionnaire to assess quality of life, 40 questions, 1-10 scale with 10 indicating more severe symptoms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03342001
|United States, Maryland|
|University of Maryland Center for Diabetes and Endocrinology|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Kashif Munir, M.D.||University of Maryland, College Park|