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

Primary Purpose

Aging, Primary Hypothyroidism, Interaction Drug Food

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Evening Levothyroxine Administration
Morning Levothyroxine Administration
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aging focused on measuring Polypharmacy, Elderly

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hospital de Clinicas de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Morning Levothyroxine Intake First

Evening Levothyroxine Intake First

Arm Description

Randomized patients to receive levothyroxine in the morning and after crossover to Evening Levothyroxine Administration.

Randomized patients to receive levothyroxine in the morning and after crossover to Morning Levothyroxine Administration.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Prevalence of drugs with potential drug interaction with levothyroxine.
To identify the major medications that interfere with the absorption of levothyroxine.
Level of TSH (Thyroid-Stimulating Hormone) control in each group.
To compare the TSH (Thyroid-Stimulating Hormone) control efficacy between the two treatment strategies in this subgroup of participants.
TSH (Thyroid-Stimulating Hormone) levels of the patients at baseline
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.

Full Information

First Posted
July 30, 2018
Last Updated
October 11, 2019
Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Federal University of Rio Grande do Sul
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1. Study Identification

Unique Protocol Identification Number
NCT03614988
Brief Title
Evaluation of Evening Versus Morning Levothyroxine Intake in Elderly
Acronym
MONIALE
Official Title
Comparative Evaluation of Evening Versus Morning Levothyroxine Administration in Treatment of Hypothyroidism in Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
November 30, 2019 (Anticipated)
Study Completion Date
March 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Federal University of Rio Grande do Sul

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Primary Hypothyroidism, Interaction Drug Food
Keywords
Polypharmacy, Elderly

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
208 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Morning Levothyroxine Intake First
Arm Type
Active Comparator
Arm Description
Randomized patients to receive levothyroxine in the morning and after crossover to Evening Levothyroxine Administration.
Arm Title
Evening Levothyroxine Intake First
Arm Type
Experimental
Arm Description
Randomized patients to receive levothyroxine in the morning and after crossover to Morning Levothyroxine Administration.
Intervention Type
Other
Intervention Name(s)
Evening Levothyroxine Administration
Other Intervention Name(s)
Bedtime Levothyroxine Administration
Intervention Description
Bedtime levothyroxine intake, with 60-minute meal-free interval
Intervention Type
Other
Intervention Name(s)
Morning Levothyroxine Administration
Other Intervention Name(s)
Before Breakfast Levothyroxine Administration
Intervention Description
Morning levothyroxine intake, 60 minutes before breakfast.
Primary Outcome Measure Information:
Title
Variation in TSH (Thyroid-Stimulating Hormone) levels.
Description
Variation in TSH (Thyroid-Stimulating Hormone) levels after 24 weeks of levothyroxine use in the evening compared to the morning period.
Time Frame
24 weeks.
Secondary Outcome Measure Information:
Title
Prevalence of drugs with potential drug interaction with levothyroxine.
Description
To identify the major medications that interfere with the absorption of levothyroxine.
Time Frame
24 weeks
Title
Level of TSH (Thyroid-Stimulating Hormone) control in each group.
Description
To compare the TSH (Thyroid-Stimulating Hormone) control efficacy between the two treatment strategies in this subgroup of participants.
Time Frame
24 weeks
Title
TSH (Thyroid-Stimulating Hormone) levels of the patients at baseline
Description
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.
Time Frame
Baseline (0 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Renato Gorga Bandeira de Mello
Phone
555133596400
Email
rgmello@hcpa.edu.br
First Name & Middle Initial & Last Name or Official Title & Degree
Karina Karina Giassi
Phone
5551998088446
Email
karinagiassi@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renato Gorga Bandeira de Mello
Organizational Affiliation
Professor of the Post Graduate Program in Endocrinology at the Hospital de Clinicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renato Gorga Bandeira de Mello
Phone
5133598152.
Email
rgmello@hcpa.edu.br

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31847914
Citation
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.
Results Reference
derived

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Evaluation of Evening Versus Morning Levothyroxine Intake in Elderly

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