Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Federal University of Rio Grande do Sul | OTHER |
Not provided
Not provided
Not provided
Not provided
A study designed to compare evening versus morning levothyroxine intake in the elderly.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Morning Levothyroxine Intake First | Active Comparator | Randomized patients to receive levothyroxine in the morning and after crossover to Evening Levothyroxine Administration. |
|
| Evening Levothyroxine Intake First | Experimental | Randomized patients to receive levothyroxine in the morning and after crossover to Morning Levothyroxine Administration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evening Levothyroxine Administration | Other | Bedtime levothyroxine intake, with 60-minute meal-free interval |
|
| 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. |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Renato Gorga Bandeira de Mello | Contact | 555133596400 | rgmello@hcpa.edu.br | |
| Karina Karina Giassi | Contact | 5551998088446 | karinagiassi@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Renato Gorga Bandeira de Mello | Professor of the Post Graduate Program in Endocrinology at the Hospital de Clinicas de Porto Alegre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Clinicas de Porto Alegre | Recruiting | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31847914 | Derived | Giassi K, Piccoli V, da Costa Rodrigues T, Gorga Bandeira de Mello R. Evaluation of evening versus morning levothyroxine intake in elderly (MONIALE). Trials. 2019 Dec 17;20(1):742. doi: 10.1186/s13063-019-3816-3. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007037 | Hypothyroidism |
| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Morning Levothyroxine Administration | Other | Morning levothyroxine intake, 60 minutes before breakfast. |
|
|
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) |