Levothyroxine Dosing in Older Individuals
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Thyroid-Related Quality of Life Patient-Reported Outcome Quality of Life scale
研究概览
简要总结
Our overall goal is to determine the clinical consequences of allowing greater flexibility in LT4 dosing in older individuals who take LT4.
详细描述
Investigators will perform a randomized, parallel, double-blind clinical trial of two 6-month dosing strategies of levothyroxine (LT4) in patients aged 65 years and older who are already taking a stable dose of at least 1.2 mcg/kg/day of LT4 therapy, one to maintain a target thyroid stimulating hormone (TSH) level of 0.5-2.0 mU/L (lower TSH group) and another of a lower levothyroxine dose to achieve a target TSH of 5.5-7.0 mU/L (higher TSH group). Investigators will assess the effects of levothyroxine therapy at two different TSH targets on symptoms of hypothyroidism, mood, sleep, measures of memory and executive function, weight, lipids, and a marker of bone turnover.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
overencapsulated levothyroxine doses will be provided by the investigational drug pharmacy
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, community dwelling, aged 65 years or older
- •Diagnosed with hypothyroidism of any etiology for at least 6 months, taking 75-200 mcg per day LT4 and a minimum of 1.2 mcg/kg/day with no dose adjustment since the last TSH test.
- •Ability to take oral medication and be willing to adhere to the medication regimen
- •Adherence to lifestyle considerations.
排除标准
- •Hypopituitarism
- •History of thyroid cancer requiring suppression of TSH secretion
- •Current use of liothyronine (LT3), thyroid extracts, Tirosint liquid or capsules, and medications that interfere with thyroid function or thyroid function tests
- •GFR <30 ml/min/1.73 m2 within the prior 12 months
- •Unable to understand and comply with study requirements, as assessed by study staff and the PI, will be excluded.
- •Other conditions which, in the opinion of the investigators, would prevent them from participating in the full duration of the study.
- •Currently taking multikinase or checkpoint inhibitor therapy.
- •Any history of food dye allergy.
研究组 & 干预措施
Lower TSH Group
Target TSH level of 0.5-2.0 mU/L
干预措施: Levothyroxine Sodium (Drug)
Higher TSH group
Target TSH level of 5.5-7.0 mU/L
干预措施: Levothyroxine Sodium (Drug)
结局指标
主要结局
Thyroid-Related Quality of Life Patient-Reported Outcome Quality of Life scale
时间窗: 6 months
22 items, scored 0-100, higher scores indicate worse status
次要结局
- Thyroid-Related Quality of Life Patient-Reported Outcome Hypothyroidism subscale b. ThyPRO "Tiredness" subscale c. Thyroid Symptoms Questionnaire (TSQ)(6 months)
- Pittsburgh Sleep Quality Index(6 months)
- Weight(6 months)
- LDL cholesterol(6 months)
- Beck Anxiety Inventory(6 months)
- Serum c-telopeptide (CTX)(6 months)
- NIH Toolbox Fluid Cognition Composite Score(6 months)
- Geriatric Depression Scale(6 months)
- Satisfaction with randomized status(6 months)
研究者
Anne Cappola, MD
Professor of Medicine, Division of Endocrinology, Diabetes and Metabolism
University of Pennsylvania