Hypothyroidism Treated With Calcitonin

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hypothyroidism

Intervention / Treatment
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* Drug: Calcitonin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Normal TSH on levothyroxine therapy Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 88 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group, open label<br>calcitonin nasal spray, 200 mcg daily | Drug: Calcitonin<br>* calcitonin nasal spray<br>* Other names: Miacalcin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified City of Hope Quality of Life Questionnaire for Patients With Thyroid Disease | 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. | 6 weeks |