Evaluation of Evening Versus Morning Levothyroxine Intake in Elderly
NCT ID: NCT03614988
Last Updated: 2019-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
208 participants
INTERVENTIONAL
2018-05-01
2020-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Morning Levothyroxine Intake First
Randomized patients to receive levothyroxine in the morning and after crossover to Evening Levothyroxine Administration.
Evening Levothyroxine Administration
Bedtime levothyroxine intake, with 60-minute meal-free interval
Evening Levothyroxine Intake First
Randomized patients to receive levothyroxine in the morning and after crossover to Morning Levothyroxine Administration.
Morning Levothyroxine Administration
Morning levothyroxine intake, 60 minutes before breakfast.
Interventions
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Evening Levothyroxine Administration
Bedtime levothyroxine intake, with 60-minute meal-free interval
Morning Levothyroxine Administration
Morning levothyroxine intake, 60 minutes before breakfast.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients diagnosed with Primary Hypothyroidism
* Patients on levothyroxine for at least 6 months
* Patients with the same dose of levothyroxine for at least 3 months
Exclusion Criteria
* Severe Congestive Heart Failure (NYHA IV or / and three or more hospitalizations for heart failure within 1-year interval)
* Diagnosis of Advanced Stage Neoplasia
* Diagnosis of Thyroid Cancer
60 Years
ALL
Yes
Sponsors
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Federal University of Rio Grande do Sul
OTHER
Hospital de Clinicas de Porto Alegre
OTHER
Responsible Party
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Principal Investigators
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Renato Gorga Bandeira de Mello
Role: PRINCIPAL_INVESTIGATOR
Professor of the Post Graduate Program in Endocrinology at the Hospital de Clinicas de Porto Alegre
Locations
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Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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Giassi K, Piccoli V, da Costa Rodrigues T, Gorga Bandeira de Mello R. Evaluation of evening versus morning levothyroxine intake in elderly (MONIALE). Trials. 2019 Dec 17;20(1):742. doi: 10.1186/s13063-019-3816-3.
Other Identifiers
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180209
Identifier Type: -
Identifier Source: org_study_id
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