Evaluation of Evening Versus Morning Levothyroxine Intake in Elderly

Overview

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

Full Title of Study: “Comparative Evaluation of Evening Versus Morning Levothyroxine Administration in Treatment of Hypothyroidism in Elderly”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: November 30, 2019

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.

Interventions

  • Other: Evening Levothyroxine Administration
    • Bedtime levothyroxine intake, with 60-minute meal-free interval
  • Other: Morning Levothyroxine Administration
    • Morning levothyroxine intake, 60 minutes before breakfast.

Arms, Groups and Cohorts

  • Active Comparator: Morning Levothyroxine Intake First
    • Randomized patients to receive levothyroxine in the morning and after crossover to Evening Levothyroxine Administration.
  • Experimental: Evening Levothyroxine Intake First
    • Randomized patients to receive levothyroxine in the morning and after crossover to Morning Levothyroxine Administration.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.
  • 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.
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Hospital de Clinicas de Porto Alegre
  • Collaborator
    • Federal University of Rio Grande do Sul
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Renato Gorga Bandeira de Mello, Principal Investigator, Professor of the Post Graduate Program in Endocrinology at the Hospital de Clinicas de Porto Alegre
  • Overall Contact(s)
    • Renato Gorga Bandeira de Mello, 555133596400, rgmello@hcpa.edu.br

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