NCT01038921已完成2 期
Melatonin Supplementation and the Metabolic Syndrome: A Phase II Crossover Design Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Metabolic Syndrome Components
研究概览
简要总结
This trial seeks to compare the effects of melatonin supplementation versus placebo in subjects with the metabolic syndrome.
详细描述
The primary purpose of this Phase II crossover design trial is to examine the safety and efficacy of 8mg of melatonin taken one hour before bedtime compared to a placebo treatment to improve at least one of the five components associated with the metabolic syndrome.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 30-79 years.
- •Diagnosed with metabolic syndrome according to AdenosineTriphosphate-III criteria.
- •Availability for six months after enrolling in the study.
排除标准
- •Inability to understand informed consent and to cooperate with study procedures.
- •Supplemental intake of melatonin.
- •Current smoking.
- •Current use of calcium channel blockers.
- •Current, planned, or recent (12 months) participation in another clinical trial.
- •Women who are pregnant, breast-feeding, attempting conception, or planning to attempt conception over the next 6 months.
- •Presence of any of the following diagnosed health conditions:
- •Active malignancy other than nonmelanoma skin cancer (current therapy for this malignancy,diagnosis within five years of enrollment, recurrence within five years of enrollment, or metastasis)
- •Uncontrolled hypothyroidism or hyperthyroidism
- •Recent (< 1 year ago) history of heart attack, bypass surgery, angioplasty, or stroke
- •Heart failure (New York Heart Association functional class 3 or 4)
- •On renal dialysis
- •Immunosuppressive therapy (systemic corticosteroids, azathioprine, methotrexate, cyclophosphamide,
- •etc.) or an immunodeficiency syndrome
- •Narcotic or alcohol dependence
- •Obstructive sleep apnea (OSA) , defined either by previous diagnosis (with or without use of nasal CPAP), or by a score of 0.80 or higher on the MAP (Multivariate Apnea Prediction), a validated screening algorithm with high positive and negative predictive value for identifying OSA.
- •Shift-workers.
研究组 & 干预措施
Melatonin
Experimental
Melatonin 8mg one hour before bedtime for 10 weeks
干预措施: Melatonin (Drug)
Placebo
Placebo Comparator
Placebo administered 1 hour before bedtime for 10 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Metabolic Syndrome Components
时间窗: 3 years
次要结局
未报告次要终点
研究者
研究点 (2)
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