Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 231 for:    CALCITONIN SALMON

Hypothyroidism Treated With Calcitonin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03342001
Recruitment Status : Completed
First Posted : November 14, 2017
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
Kashif Munir, University of Maryland, College Park

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
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 : June 18, 2018
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : August 14, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothyroidism

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




Primary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 88 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03342001


Locations
Layout table for location information
United States, Maryland
University of Maryland Center for Diabetes and Endocrinology
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland, Baltimore
Investigators
Layout table for investigator information
Principal Investigator: Kashif Munir, M.D. University of Maryland, College Park

Publications:
Layout table for additonal information
Responsible Party: Kashif Munir, MD, University of Maryland, College Park
ClinicalTrials.gov Identifier: NCT03342001     History of Changes
Other Study ID Numbers: HP-00076671
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Calcitonin
Salmon calcitonin
Calcitonin Gene-Related Peptide
Katacalcin
Hypothyroidism
Thyroid Diseases
Endocrine System Diseases
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Vasodilator Agents