Hypothyroidism Treated With Calcitonin
Primary Purpose
Hypothyroidism
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Calcitonin
Sponsored by
About this trial
This is an interventional treatment trial for Hypothyroidism
Eligibility Criteria
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
Sites / Locations
- University of Maryland Center for Diabetes and Endocrinology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment group, open label
Arm Description
calcitonin nasal spray, 200 mcg daily
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03342001
First Posted
November 9, 2017
Last Updated
February 17, 2022
Sponsor
University of Maryland, Baltimore
1. Study Identification
Unique Protocol Identification Number
NCT03342001
Brief Title
Hypothyroidism Treated With Calcitonin
Official Title
Assessing Quality of Life Changes Using Calcitonin in Patients With Hypothyroidism on Biochemical Replacement With Levothyroxine
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 18, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
August 14, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothyroidism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment group, open label
Arm Type
Experimental
Arm Description
calcitonin nasal spray, 200 mcg daily
Intervention Type
Drug
Intervention Name(s)
Calcitonin
Other Intervention Name(s)
Miacalcin
Intervention Description
calcitonin nasal spray
Primary Outcome Measure Information:
Title
Modified City of Hope Quality of Life Questionnaire for Patients With Thyroid Disease
Description
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.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kashif Munir, M.D.
Organizational Affiliation
University of Maryland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland Center for Diabetes and Endocrinology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
12390330
Citation
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.
Results Reference
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Hypothyroidism Treated With Calcitonin
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