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

Hospital de Clinicas de Porto Alegre

Status: Unknown

Conditions: Interaction Drug Food; Aging; Primary Hypothyroidism

Treatments: Other: Morning Levothyroxine Administration; Other: Evening Levothyroxine Administration

Study type: Interventional

Funder types: Other

Identifiers

NCT03614988

180209

Details and patient eligibility

About

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

Full 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.

Enrollment: 208 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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208 participants in 2 patient groups

Morning Levothyroxine Intake First

Active Comparator group

Description:

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

Treatment:

Other: Evening Levothyroxine Administration

Evening Levothyroxine Intake First

Experimental group

Description:

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

Treatment:

Other: Morning Levothyroxine Administration