Comparative Evaluation of Evening Versus Morning Levothyroxine Administration in Treatment of Hypothyroidism in Elderly
试验速览
- 阶段
- 不适用
- 入组人数
- 208
- 试验地点
- 2
- 主要终点
- Variation in TSH (Thyroid-Stimulating Hormone) levels.
研究概览
简要总结
A study designed to compare evening versus morning levothyroxine intake in the elderly.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Morning Levothyroxine Intake First
Randomized patients to receive levothyroxine in the morning and after crossover to Evening Levothyroxine Administration.
干预措施: Evening Levothyroxine Administration (Other)
Evening Levothyroxine Intake First
Randomized patients to receive levothyroxine in the morning and after crossover to Morning Levothyroxine Administration.
干预措施: Morning Levothyroxine Administration (Other)
结局指标
主要结局
Variation in TSH (Thyroid-Stimulating Hormone) levels.
时间窗: 24 weeks.
Variation in TSH (Thyroid-Stimulating Hormone) levels after 24 weeks of levothyroxine use in the evening compared to the morning period.
次要结局
- TSH (Thyroid-Stimulating Hormone) levels of the patients at baseline(Baseline (0 weeks))
- Prevalence of drugs with potential drug interaction with levothyroxine.(24 weeks)
- Level of TSH (Thyroid-Stimulating Hormone) control in each group.(24 weeks)