Hypothyroidism Treated With Calcitonin

Phase 4

Completed

• Conditions: Hypothyroidism
• Interventions: Drug: Calcitonin

• Registration Number: NCT03342001
• Lead Sponsor: University of Maryland, Baltimore

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 Timeline

• Study First Submitted: 2017-11-09
• Study First Submitted QC: 2017-11-09
• Study First Posted: 2017-11-14
• Study Start: 2018-06-18
• Primary Completion: 2019-06-30
• Study Completion: 2019-08-14
• Results First Submitted: 2021-04-26
• Results First Submitted QC: 2021-05-14
• Results First Posted: 2021-06-10
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-17
• Last Update Posted: 2022-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Normal TSH on levothyroxine therapy

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Exclusion Criteria

1. pregnant or 6 months post partum
2. Current or previous thyroid cancer
3. Congenital hypothyroidism
4. any tobacco use
5. prescribed proton pump inhibitors
6. prescribed steroids
7. taking armour thyroid, naturethroid, or any dessicated thyroid hormone
8. Unstable medical conditions (CKD, Cirrhosis etc)
9. pituitary disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group, open label	Calcitonin	calcitonin nasal spray, 200 mcg daily

Primary Outcome Measures

Name	Time	Method
Modified City of Hope Quality of Life Questionnaire for Patients With Thyroid Disease	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.

Trial Locations

Locations (1)

University of Maryland Center for Diabetes and Endocrinology; 🇺🇸 Baltimore, Maryland, United States