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OpenTrials
Completed

NCT Number: NCT03342001

Hypothyroidism Treated With Calcitonin

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.

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Key information

Age range

18 year–88 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Maryland Center for Diabetes and Endocrinology

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Calcitonin

Drug

calcitonin nasal spray

Other names: Miacalcin

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 14, 2017
Registry last updated
Feb 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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