Evaluation of Evening Versus Morning Levothyroxine Intake in Elderly (MONIALE)
October 11, 2019 updated by: Hospital de Clinicas de Porto Alegre
Comparative Evaluation of Evening Versus Morning Levothyroxine Administration in Treatment of Hypothyroidism in Elderly
A study designed to compare evening versus morning levothyroxine intake in the elderly.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
This is a randomized crossover trial of two dosing strategies for pharmacological treatment of hypothyroidism in a sample of individuals aged 60 years or older, performed at an outpatient healthcare in a tertiary center.
Study Type
Interventional
Enrollment (Anticipated)
208
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rio Grande Do Sul
-
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
- Recruiting
- Hospital de Clínicas de Porto Alegre
-
Contact:
- Renato Gorga Bandeira de Mello
- Phone Number: 5133598152.
- Email: rgmello@hcpa.edu.br
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Individuals aged 60 years or older who consult at the Geriatrics, Endocrinology and Internal Medicine Clinic at Hospital Clinicas de Porto Alegre
- 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 Dementia
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Morning Levothyroxine Intake First
Randomized patients to receive levothyroxine in the morning and after crossover to Evening Levothyroxine Administration.
|
Bedtime levothyroxine intake, with 60-minute meal-free interval
Other Names:
|
|
Experimental: Evening Levothyroxine Intake First
Randomized patients to receive levothyroxine in the morning and after crossover to Morning Levothyroxine Administration.
|
Morning levothyroxine intake, 60 minutes before breakfast.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Variation in TSH (Thyroid-Stimulating Hormone) levels.
Time Frame: 24 weeks.
|
Variation in TSH (Thyroid-Stimulating Hormone) levels after 24 weeks of levothyroxine use in the evening compared to the morning period.
|
24 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of drugs with potential drug interaction with levothyroxine.
Time Frame: 24 weeks
|
To identify the major medications that interfere with the absorption of levothyroxine.
|
24 weeks
|
|
Level of TSH (Thyroid-Stimulating Hormone) control in each group.
Time Frame: 24 weeks
|
To compare the TSH (Thyroid-Stimulating Hormone) control efficacy between the two treatment strategies in this subgroup of participants.
|
24 weeks
|
|
TSH (Thyroid-Stimulating Hormone) levels of the patients at baseline
Time Frame: Baseline (0 weeks)
|
To assess the TSH (Thyroid-Stimulating Hormone) levels in this sample of patients at the time of study inclusion, in order to evaluate their real life in terms of adherence and relation with polypharmacy.
|
Baseline (0 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Renato Gorga Bandeira de Mello, Professor of the Post Graduate Program in Endocrinology at the Hospital de Clinicas de Porto Alegre
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2018
Primary Completion (Anticipated)
November 30, 2019
Study Completion (Anticipated)
March 31, 2020
Study Registration Dates
First Submitted
July 30, 2018
First Submitted That Met QC Criteria
July 30, 2018
First Posted (Actual)
August 3, 2018
Study Record Updates
Last Update Posted (Actual)
October 14, 2019
Last Update Submitted That Met QC Criteria
October 11, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 180209
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.