Single-center, Randomized, Double-Blinded, Comparative Study of the Effectiveness of L-carnitine in Patients'Fatigue Degree Changing With Hypothyroidism Who Take Levothyroxine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Fatigue Severity scale
研究概览
简要总结
L-carnitine and thyroid hormone tended to antagonize reciprocally in human body. Urinary excretion of L-carnitine decreased in hypothyroid patients, and levothyroxine supplementation increased excretion of L-carnitine. The investigators hypothesized that supplying L-carnitine to hypothyroid patients with fatigue symptom could improve the quality of life, and fatigue score in them. Therefore, the investigators planned to compare the efficacy of L-carnitine and placebo in hypothyroid patients who had taken levothyroxine.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of hypothyroidism with fatigue symptom
- •Currently use of the same amount of levothyroxine over at least six months
- •Normal serum free T4 level
排除标准
- •Current smoker
- •Serum hemoglobin level of under 12mg/dL
- •Clinical diagnosis of diabetes mellitus or fasting serum glucose level ≥ 126mg/dL or HbA1c level ≥ 6.5%
- •History of significant heart failure
- •History of large amount of alcohol consumption
- •Uncontrolled hypertension (systolic blood pressure ≥ 160 millimeter of mercury (mmHg) or diastolic blood pressure ≥ 100 mmHg
- •pregnant, or planning to be pregnant, or breast feeding women
- •aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2 times of normal limit
- •serum Cr level > 2.0mg/dL
研究组 & 干预措施
L-carnitine
L-carnitine 330mg, 3 tablet twice daily
干预措施: L-carnitine (Drug)
Placebo
placebo drug, 3 tablet twice daily
干预措施: Placebo (Drug)
结局指标
主要结局
Fatigue Severity scale
时间窗: baseline and 12 weeks
Change from Baseline in Fatigue severity scale at 12 weeks (scoring 'fatigue severity scale' at baseline and 12 weeks)
次要结局
- Wessely and Powell score(baseline and 12 weeks)
研究者
Sin Gon Kim
Professor
Korea University Anam Hospital