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Evaluation of Evening Versus Morning Levothyroxine Intake in Elderly (MONIALE)

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ClinicalTrials.gov Identifier: NCT03614988
Recruitment Status : Recruiting
First Posted : August 3, 2018
Last Update Posted : October 14, 2019
Sponsor:
Collaborator:
Federal University of Rio Grande do Sul
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Brief Summary:
A study designed to compare evening versus morning levothyroxine intake in the elderly.

Condition or disease Intervention/treatment Phase
Aging Primary Hypothyroidism Interaction Drug Food Other: Evening Levothyroxine Administration Other: Morning Levothyroxine Administration Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Evaluation of Evening Versus Morning Levothyroxine Administration in Treatment of Hypothyroidism in Elderly
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothyroidism

Arm Intervention/treatment
Active Comparator: Morning Levothyroxine Intake First
Randomized patients to receive levothyroxine in the morning and after crossover to Evening Levothyroxine Administration.
Other: Evening Levothyroxine Administration
Bedtime levothyroxine intake, with 60-minute meal-free interval
Other Name: Bedtime Levothyroxine Administration

Experimental: Evening Levothyroxine Intake First
Randomized patients to receive levothyroxine in the morning and after crossover to Morning Levothyroxine Administration.
Other: Morning Levothyroxine Administration
Morning levothyroxine intake, 60 minutes before breakfast.
Other Name: Before Breakfast Levothyroxine Administration




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03614988


Contacts
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Contact: Renato Gorga Bandeira de Mello 555133596400 rgmello@hcpa.edu.br
Contact: Karina Karina Giassi 5551998088446 karinagiassi@hotmail.com

Locations
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Brazil
Hospital de Clinicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Contact: Renato Gorga Bandeira de Mello    5133598152.    rgmello@hcpa.edu.br   
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Federal University of Rio Grande do Sul
Investigators
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Principal Investigator: Renato Gorga Bandeira de Mello Professor of the Post Graduate Program in Endocrinology at the Hospital de Clinicas de Porto Alegre
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT03614988    
Other Study ID Numbers: 180209
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital de Clinicas de Porto Alegre:
Polypharmacy
Elderly
Additional relevant MeSH terms:
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Hypothyroidism
Thyroid Diseases
Endocrine System Diseases