Hypothyroidism Treated With Calcitonin

• Sponsor: University of Maryland, Baltimore (Other)
• Overall Status: Completed
• CT.gov ID: NCT03342001
• Collaborator: (none)
• Enrollment: 11
• Location: 1
• Arm: 1
• Actual Duration (Months): 13.9
• Patients Per Site Per Month: 0.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypothyroidism	Drug: Calcitonin	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Assessing Quality of Life Changes Using Calcitonin in Patients With Hypothyroidism on Biochemical Replacement With Levothyroxine
• Actual Study Start Date: Jun 18, 2018
• Actual Primary Completion Date: Jun 30, 2019
• Actual Study Completion Date: Aug 14, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment group, open label calcitonin nasal spray, 200 mcg daily	Drug: Calcitonin; calcitonin nasal spray; Other Names: Miacalcin

Outcome Measures

Primary Outcome Measures

1. Modified City of Hope Quality of Life Questionnaire for Patients With Thyroid Disease [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 88 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Maryland Center for Diabetes and Endocrinology	Baltimore	Maryland	United States	21201

Sponsors and Collaborators

• University of Maryland, Baltimore

Investigators

• Principal Investigator: Kashif Munir, M.D., University of Maryland

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 9, 2017

More Information

Publications

• 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.

• Responsible Party: Kashif Munir, MD, University of Maryland, Baltimore
• ClinicalTrials.gov Identifier: NCT03342001
• Other Study ID Numbers: HP-00076671
• First Posted: Nov 14, 2017
• Last Update Posted: Feb 21, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypothyroidism; Calcitonin; Salmon calcitonin; Calcitonin Gene-Related Peptide; Katacalcin

Study Results

Participant Flow

Arm/Group Title	Treatment Group, Open Label
Arm/Group Description	calcitonin nasal spray, 200 mcg daily Calcitonin: calcitonin nasal spray
Period Title: Overall Study
STARTED	11
COMPLETED	9
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Calcitonin
Arm/Group Description	People with hypothyroidism
Overall Participants	11
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	8 72.7%
>=65 years	3 27.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63 (22)
Sex: Female, Male (Count of Participants)
Female	11 100%
Male	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 18.2%
White	9 81.8%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	11 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

participants completing trial

Arm/Group Title	Treatment Group, Open Label
Arm/Group Description	calcitonin nasal spray, 200 mcg daily Calcitonin: calcitonin nasal spray
Measure Participants	9
Mean (Standard Deviation) [score on a scale]	-36.33 (39.41)

Adverse Events

Time Frame	Only during trial 6 weeks per participant
Adverse Event Reporting Description	Low risk trial and no reasonable expectation of serious adverse event or mortality
Arm/Group Title	Treatment Group, Open Label
Arm/Group Description	calcitonin nasal spray, 200 mcg daily Calcitonin: calcitonin nasal spray
All Cause Mortality
	Treatment Group, Open Label
	Affected / at Risk (%)	# Events
Total	0/11 (0%)
Serious Adverse Events
	Treatment Group, Open Label
	Affected / at Risk (%)	# Events
Total	0/11 (0%)
Other (Not Including Serious) Adverse Events
	Treatment Group, Open Label
	Affected / at Risk (%)	# Events
Total	2/11 (18.2%)
Gastrointestinal disorders
nausea	1/11 (9.1%)	1
Renal and urinary disorders
kidney stone	1/11 (9.1%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.