Evaluation of Evening Versus Morning Levothyroxine Intake in Elderly
MONIALE
Comparative Evaluation of Evening Versus Morning Levothyroxine Administration in Treatment of Hypothyroidism in Elderly
1 other identifier
interventional
208
1 country
1
Brief Summary
A study designed to compare evening versus morning levothyroxine intake in the elderly.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2018
CompletedFirst Submitted
Initial submission to the registry
July 30, 2018
CompletedFirst Posted
Study publicly available on registry
August 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2020
CompletedOctober 14, 2019
October 1, 2019
1.6 years
July 30, 2018
October 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Variation in TSH (Thyroid-Stimulating Hormone) levels.
Variation in TSH (Thyroid-Stimulating Hormone) levels after 24 weeks of levothyroxine use in the evening compared to the morning period.
24 weeks.
Secondary Outcomes (3)
Prevalence of drugs with potential drug interaction with levothyroxine.
24 weeks
Level of TSH (Thyroid-Stimulating Hormone) control in each group.
24 weeks
TSH (Thyroid-Stimulating Hormone) levels of the patients at baseline
Baseline (0 weeks)
Study Arms (2)
Morning Levothyroxine Intake First
ACTIVE COMPARATORRandomized patients to receive levothyroxine in the morning and after crossover to Evening Levothyroxine Administration.
Evening Levothyroxine Intake First
EXPERIMENTALRandomized patients to receive levothyroxine in the morning and after crossover to Morning Levothyroxine Administration.
Interventions
Bedtime levothyroxine intake, with 60-minute meal-free interval
Morning levothyroxine intake, 60 minutes before breakfast.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Related Publications (1)
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.
PMID: 31847914DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Renato Gorga Bandeira de Mello
Professor of the Post Graduate Program in Endocrinology at the Hospital de Clinicas de Porto Alegre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2018
First Posted
August 3, 2018
Study Start
May 1, 2018
Primary Completion
November 30, 2019
Study Completion
March 31, 2020
Last Updated
October 14, 2019
Record last verified: 2019-10