NCT07424183尚未招募2 期
T4/T3 Therapy in Hypothyroidism
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- ThyPRO Composite QOL Scale
研究概览
简要总结
This study will test whether 6 months of combination therapy with levothyroxine (LT4) plus liothyronine (LT3) is superior to LT4 plus placebo in participants with hypothyroidism who have residual symptoms of hypothyroidism with TSH levels within the reference range.
详细描述
.Participants will
- Take LT4+LT3 or LT4+placebo for 6 months
- Visit the clinic at the beginning and the end of the study for a blood test and to answer questionnaires.
- Have blood tests checked at 6 and 13 weeks and symptom checks by text (weekly to monthly)
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)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18-70 years
- •Hypothyroidism due to either thyroid failure or total thyroidectomy for structural thyroid disease (nodules, benign goiter, or thyroid cancer) for at least 6 months
- •Taking 75-150 mcg per day LT4 and a minimum of 1.2 mcg/kg/day, with stable dose of LT4 for at least 3 months prior to enrollment
- •TSH of 0.5 to 4.0 mU/L within 2 months of enrollment
- •Persistent symptoms for at least 2 months, and a TSQ score of ≥ 5
- •For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of study intervention.
排除标准
- •Current use of LT3, thyroid extracts, Tirosint liquid or capsules, amiodarone, lithium, methimazole, propylthiouracil, supraphysiologic doses of corticosteroids, immunotherapy, tyrosine kinase inhibitors, interferon, or biotin supplements
- •Diseases of the pituitary or hypothalamus
- •History of thyroid cancer requiring suppression of TSH secretion
- •Unstable cardiac conditions, including uncontrolled hypertension (current blood pressure greater than 160/100), arrhythmia, or angina
- •Uncontrolled psychiatric disorders
- •Pregnancy or lactation, or planned pregnancy within the next 7 months
- •History of food dye allergies
- •GFR <30 ml/min/1.73 m2
- •Other conditions which, in the opinion of the investigators, would prevent them from participating in the full duration of the study (for example, end-stage cancer)
研究组 & 干预措施
LT4+LT3
Experimental
Levothyroxine plus liothyronine therapy
干预措施: Liothyronine (L-T3) (Drug)
LT4+placebo
Active Comparator
Levothyroxine plus liothyronine placebo
干预措施: Levothyroxine Sodium (LT4) Tablets (Drug)
LT4+LT3
Experimental
Levothyroxine plus liothyronine therapy
干预措施: Levothyroxine Sodium (LT4) Tablets (Drug)
LT4+placebo
Active Comparator
Levothyroxine plus liothyronine placebo
干预措施: Liothyronine (LT3) placebo (Drug)
结局指标
主要结局
ThyPRO Composite QOL Scale
时间窗: 6 months
22 items, scored 0-100, higher scores indicate worse status
次要结局
- LDL cholesterol(6 months)
- Serum c-telopeptide(6 months)
- ThyPRO subscales(6 months)
- Thyroid Symptoms Questionnaire (TSQ)(6 months)
- Cognitive measures(Baseline and 6 months)
- Beck Depression Inventory(Baseline and 6 months)
- Beck Anxiety Inventory(Baseline and 6 months)
- Pittsburgh Sleep Quality Index(6 months)
- Weight(6 months)
- Satisfaction with randomized status(6 months)
研究者
Anne Cappola, MD
Professor of Medicine
University of Pennsylvania
研究点 (1)
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