Evaluation of Evening Versus Morning Levothyroxine Intake in Elderly

Not Applicable

• Conditions: Primary Hypothyroidism; Aging; Interaction Drug Food
• Interventions: Other: Evening Levothyroxine Administration; Other: Morning Levothyroxine Administration

• Registration Number: NCT03614988
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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.

Study Timeline

• Study Start: 2018-05-01
• Study First Submitted: 2018-07-30
• Study First Submitted QC: 2018-07-30
• Study First Posted: 2018-08-03
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-11
• Last Update Posted: 2019-10-14
• Primary Completion: 2019-11-30
• Study Completion: 2020-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 208

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Morning Levothyroxine Intake First	Evening Levothyroxine Administration	Randomized patients to receive levothyroxine in the morning and after crossover to Evening Levothyroxine Administration.
Evening Levothyroxine Intake First	Morning Levothyroxine Administration	Randomized patients to receive levothyroxine in the morning and after crossover to Morning Levothyroxine Administration.

Primary Outcome Measures

Name	Time	Method
Variation in TSH (Thyroid-Stimulating Hormone) levels.	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

Name	Time	Method
TSH (Thyroid-Stimulating Hormone) levels of the patients at baseline	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.
Prevalence of drugs with potential drug interaction with levothyroxine.	24 weeks	To identify the major medications that interfere with the absorption of levothyroxine.
Level of TSH (Thyroid-Stimulating Hormone) control in each group.	24 weeks	To compare the TSH (Thyroid-Stimulating Hormone) control efficacy between the two treatment strategies in this subgroup of participants.

Trial Locations

Locations (1)

Hospital de Clinicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil