Evaluation of Evening Versus Morning Levothyroxine Intake in Elderly (MONIALE)
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|ClinicalTrials.gov Identifier: NCT03614988|
Recruitment Status : Recruiting
First Posted : August 3, 2018
Last Update Posted : October 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Aging Primary Hypothyroidism Interaction Drug Food||Other: Evening Levothyroxine Administration Other: Morning Levothyroxine Administration||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||208 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Comparative Evaluation of Evening Versus Morning Levothyroxine Administration in Treatment of Hypothyroidism in Elderly|
|Actual Study Start Date :||May 1, 2018|
|Estimated Primary Completion Date :||November 30, 2019|
|Estimated Study Completion Date :||March 31, 2020|
Active Comparator: Morning Levothyroxine Intake First
Randomized patients to receive levothyroxine in the morning and after crossover to Evening Levothyroxine Administration.
Other: Evening Levothyroxine Administration
Bedtime levothyroxine intake, with 60-minute meal-free interval
Other Name: Bedtime Levothyroxine Administration
Experimental: Evening Levothyroxine Intake First
Randomized patients to receive levothyroxine in the morning and after crossover to Morning Levothyroxine Administration.
Other: Morning Levothyroxine Administration
Morning levothyroxine intake, 60 minutes before breakfast.
Other Name: Before Breakfast Levothyroxine Administration
- Variation in TSH (Thyroid-Stimulating Hormone) levels. [ Time Frame: 24 weeks. ]Variation in TSH (Thyroid-Stimulating Hormone) levels after 24 weeks of levothyroxine use in the evening compared to the morning period.
- Prevalence of drugs with potential drug interaction with levothyroxine. [ Time Frame: 24 weeks ]To identify the major medications that interfere with the absorption of levothyroxine.
- Level of TSH (Thyroid-Stimulating Hormone) control in each group. [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03614988
|Contact: Renato Gorga Bandeira de Melloemail@example.com|
|Contact: Karina Karina Giassifirstname.lastname@example.org|
|Hospital de Clinicas de Porto Alegre||Recruiting|
|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|
|Contact: Renato Gorga Bandeira de Mello 5133598152. email@example.com|
|Principal Investigator:||Renato Gorga Bandeira de Mello||Professor of the Post Graduate Program in Endocrinology at the Hospital de Clinicas de Porto Alegre|