Current partner codePEPTIDESDE
NCT03342001·Phase 4·INTERVENTIONAL

Hypothyroidism Treated With Calcitonin

Status

Completed

Phase

Phase 4

Enrollment

11

Locations

1

Results

Posted

Publications

1

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

DRUG

Calcitonin

calcitonin nasal spray

Timeline

From registration to results.

  1. First posted

    Nov 14, 2017

  2. Study start

    Jun 18, 2018

  3. Primary completion

    Jun 30, 2019

  4. Study completion

    Aug 14, 2019

  5. Results posted

    Jun 10, 2021

  6. Registry updated

    Feb 21, 2022

Outcomes

What the study measures.

Primary outcomes

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. Total 400 points, primary assessment was change in score after 6 weeks.

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
88 Years
Sex
ALL
Healthy volunteers
Yes

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

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

University of Maryland Center for Diabetes and Endocrinology

Baltimore, Maryland, United States

Related trials

More studies on Calcitonin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.