Hypothyroidism Treated With Calcitonin

NCTNCT03342001Other idHP-00076671

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 4
Enrollment: 11 participants (actual)
Sponsor: University of Maryland, Baltimore · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: 18 Jun 2018
Primary completion: 30 Jun 2019
Completion: 14 Aug 2019
First posted: 14 Nov 2017
Last update posted: 21 Feb 2022
Conditions: Hypothyroidism

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201820192020

Ph 4
Hypothyroidism Treated With Calcitonin
NCT03342001
18 Jun 2018 to 14 Aug 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

CalcitoninDrug

Arms1

Experimental
Treatment group, open label
calcitonin nasal spray, 200 mcg daily

Primary outcomes1

Outcomes the sponsor listed as primary.

Modified City of Hope Quality of Life Questionnaire for Patients With Thyroid Disease
Time frame · 6 weeks
Registry 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 6 weeks

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

Group	Value (score on a scale)	Spread
Treatment Group, Open Label	-36.33	39.41

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Treatment Group, Open Labelcalcitonin nasal spray, 200 mcg daily Calcitonin: calcitonin nasal spray	0 / 11	0 / 11	2 / 11

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 88 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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

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