Hypothyroidism Treated With Calcitonin
Assessing Quality of Life Changes Using Calcitonin in Patients With Hypothyroidism on Biochemical Replacement With Levothyroxine
1 other identifier
interventional
11
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jun 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2017
CompletedFirst Posted
Study publicly available on registry
November 14, 2017
CompletedStudy Start
First participant enrolled
June 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 14, 2019
CompletedResults Posted
Study results publicly available
June 10, 2021
CompletedFebruary 21, 2022
February 1, 2022
1 year
November 9, 2017
April 26, 2021
February 17, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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.
6 weeks
Study Arms (1)
Treatment group, open label
EXPERIMENTALcalcitonin nasal spray, 200 mcg daily
Interventions
Eligibility Criteria
You may qualify if:
- Normal TSH on levothyroxine therapy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Maryland Center for Diabetes and Endocrinology
Baltimore, Maryland, 21201, United States
Related Publications (1)
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.
PMID: 12390330BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Kashif Munir
- Organization
- University of Maryland School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Kashif Munir, M.D.
University of Maryland
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
November 9, 2017
First Posted
November 14, 2017
Study Start
June 18, 2018
Primary Completion
June 30, 2019
Study Completion
August 14, 2019
Last Updated
February 21, 2022
Results First Posted
June 10, 2021
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share