Evaluation of Evening Versus Morning Levothyroxine Intake in Elderly

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

Detailed Description
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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.

Official Title
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Comparative Evaluation of Evening Versus Morning Levothyroxine Administration in Treatment of Hypothyroidism in Elderly

Conditions
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Aging, Primary Hypothyroidism, Interaction Drug Food

Intervention / Treatment
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* Other: Evening Levothyroxine Administration
* Other: Morning Levothyroxine Administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Morning Levothyroxine Intake First<br>Randomized patients to receive levothyroxine in the morning and after crossover to Evening Levothyroxine Administration. | Other: Evening Levothyroxine Administration<br>* Bedtime levothyroxine intake, with 60-minute meal-free interval<br>* Other names: Bedtime Levothyroxine Administration;|
| Experimental: Evening Levothyroxine Intake First<br>Randomized patients to receive levothyroxine in the morning and after crossover to Morning Levothyroxine Administration. | Other: Morning Levothyroxine Administration<br>* Morning levothyroxine intake, 60 minutes before breakfast.<br>* Other names: Before Breakfast Levothyroxine Administration;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of drugs with potential drug interaction with levothyroxine. | To identify the major medications that interfere with the absorption of levothyroxine. | 24 weeks | 
| 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. | 24 weeks | 
| 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. | Baseline (0 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polypharmacy, Elderly