Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 246 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

Tracking Information
First Submitted Date  ICMJE November 9, 2017
First Posted Date  ICMJE November 14, 2017
Last Update Posted Date August 16, 2019
Actual Study Start Date  ICMJE June 18, 2018
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: November 9, 2017)
Quality of Life [ Time Frame: 6 weeks ]
questionnaire
Change History Complete list of historical versions of study NCT03342001 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hypothyroidism Treated With Calcitonin
Official Title  ICMJE Assessing Quality of Life Changes Using Calcitonin in Patients With Hypothyroidism on Biochemical Replacement With Levothyroxine
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypothyroidism
Intervention  ICMJE Drug: Calcitonin
calcitonin nasal spray
Other Name: Miacalcin
Study Arms  ICMJE Experimental: Treatment group, open label
calcitonin nasal spray, 200 mcg daily
Intervention: Drug: Calcitonin
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 18, 2019)
11
Original Estimated Enrollment  ICMJE
 (submitted: November 9, 2017)
30
Actual Study Completion Date  ICMJE August 14, 2019
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 88 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03342001
Other Study ID Numbers  ICMJE HP-00076671
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kashif Munir, University of Maryland, College Park
Study Sponsor  ICMJE University of Maryland, Baltimore
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kashif Munir, M.D. University of Maryland, College Park
PRS Account University of Maryland, Baltimore
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP