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Hypothyroidism Treated With Calcitonin
Plain-language guide to NCT03342001: phase 4 interventional trial of Calcitonin, 11 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03342001
- Phase
- phase 4
- Status
- completed
- Start
- 2018-06-18
- Completion (planned or actual)
- 2019-06-30
- Participants
- 11 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Hypothyroidism
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Calcitonin.
Some people with hypothyroidism have persistent symptoms despite adequate treatment with thyroid hormones.
It had 1 arm (groups): Treatment group, open label (experimental).
The registry classes the interventions as drug.
More on the Plan
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.
These patients are challenging to manage and are often unhappy with they care.
Established treatment of hypothyroidism is levothyroxine.
Who Took Part
11 actual participants took part.
It was open to people of any sex aged from 18 years up to 88 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Normal TSH on levothyroxine therapy.
The full record lists 1 inclusion and 9 exclusion criteria; among the exclusions: pregnant or 6 months post partum; current or previous thyroid cancer; congenital hypothyroidism.
How the Study Was Run
The set-up was single-group and open-label.
Everyone knew when Calcitonin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2018-06-18 with completion listed for 2019-06-30.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Modified City of Hope Quality of Life Questionnaire for Patients With Thyroid Disease (time frame: 6 weeks).
What This Means in Plain Language
Put simply, this is a phase 4 trial of Calcitonin in 11 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Calcitonin compound page, all human trials.
Our Notes on the Compound
Calcitonin: A 32-amino-acid hormone that lowers blood calcium; salmon calcitonin (Miacalcin) has been used for Paget disease and osteoporosis.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.