Aging, Interaction Drug Food, Primary Hypothyroidism
Conditions
Keywords
Polypharmacy, Elderly
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.
Interventions
OTHEREvening Levothyroxine Administration
Bedtime levothyroxine intake, with 60-minute meal-free interval
OTHERMorning Levothyroxine Administration
Morning levothyroxine intake, 60 minutes before breakfast.
Sponsors
Federal University of Rio Grande do Sul
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Brazil
Contacts
Primary ContactRenato Gorga Bandeira de Mello
Backup ContactKarina Karina Giassi
Outcome results
None listed