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Isolated ACTH Deficiency in Patients With Hashimoto Thyroiditis
Plain-language guide to NCT00552487: not phased interventional trial of Cosyntropin, 62 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00552487
- Phase
- not phased
- Status
- completed
- Start
- 2005-10
- Completion (planned or actual)
- 2006-07
- Participants
- 62 (actual)
- Design
- open label (everyone knows who gets what), diagnostic
- Conditions studied
- Hashimoto Disease; Adrenal Insufficiency
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested Cosyntropin.
The purpose of this study is to determine whether patients with Hashimoto thyroiditis and impaired well-being may have a partial secondary adrenocortical insufficiency.
It had four arms (groups): 1 (other), 2 (other), 3 (other) and 4 (other).
The registry classes the interventions as drug.
More on the Plan
Many patients with Hashimoto thyroiditis who are correctly substituted with thyroid hormones have an impaired well-being. in some people an isolated ACTH deficiency was found.
Who Took Part
62 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Hashimoto thyroiditis euthyreot thyroid function with levothyroxin therapy written informed consent.
The full record lists 1 inclusion and 5 exclusion criteria; among the exclusions: • hypothyroidism of other origin; pregnancy and lactation; oral contraception.
How the Study Was Run
It was run as a parallel-group and open-label study.
The Cosyntropin group and the comparison group ran side by side rather than switching.
Everyone knew when Cosyntropin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 2005-10 with completion listed for 2006-07.
It ran at 1 site in Germany.
Its stated primary purpose is diagnostic.
What Was Measured
Researchers chose this as the main measure: serum cortisol-peak 30 min after ACTH-stimulation (time frame: 30 minutes).
It also tracked 1 secondary outcome, for example serum DHEA-peak 30 min. after ACTH-stimulation,DHEA-S, ACTH.
What This Means in Plain Language
Put simply, this is a not phased trial of Cosyntropin in 62 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Cosyntropin compound page, all human trials.
Our Notes on the Compound
Cosyntropin: A synthetic 24-amino-acid fragment of ACTH (also tetracosactide, Synacthen) used mainly in the adrenal stimulation test.
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.