Hypothyroidism Treated With Calcitonin

NCT ID: NCT03342001

Last Updated: 2022-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-18
• Study Completion Date: 2019-08-14

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.

Conditions

Hypothyroidism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group, open label

calcitonin nasal spray, 200 mcg daily

Group Type: EXPERIMENTAL

Calcitonin

Intervention Type: DRUG

calcitonin nasal spray

Interventions

Calcitonin

calcitonin nasal spray

Intervention Type: DRUG

Other Intervention Names

Miacalcin

Eligibility Criteria

Inclusion Criteria

• Normal TSH on levothyroxine therapy

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 88 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Kashif Munir

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kashif Munir, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Maryland

Locations

University of Maryland Center for Diabetes and Endocrinology

Baltimore, Maryland, United States

Countries

United States

References

Saravanan P, Chau WF, Roberts N, Vedhara K, Greenwood R, Dayan CM. Psychological well-being in patients on 'adequate' doses of l-thyroxine: results of a large, controlled community-based questionnaire study. Clin Endocrinol (Oxf). 2002 Nov;57(5):577-85. doi: 10.1046/j.1365-2265.2002.01654.x.

Reference Type: BACKGROUND

PMID: 12390330 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HP-00076671

Identifier Type: -

Identifier Source: org_study_id