Evaluation of Evening Versus Morning Levothyroxine Intake in Elderly

Aging Clinical Trial

— MONIALE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03614988
• Other study ID #: 180209
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: March 31, 2020

Study information

• Verified date: October 2019
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Renato Gorga Bandeira de Mello
• Phone: 555133596400
• Email: rgmello[@]hcpa.edu.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 208
• Est. completion date: March 31, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Hypothyroidism
• Interaction Drug Food
• Primary Hypothyroidism

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Prevalence of drugs with potential drug interaction with levothyroxine.	To identify the major medications that interfere with the absorption of levothyroxine.	24 weeks
Secondary	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
Secondary	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)