Effects of Melatonin on Oxygen Consumption and Choroidal Blood Flow in Women With Vasospastic Syndrome in Comparison to Controls
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- -choroidal blood flow -oxygen consumption -Co2 production -skin temperatures -rectal temperatures -blood pressure -eye tension
研究概览
简要总结
Does melatonin affect basal metabolic rate, increase choroidal blood flow and reduce the vasospastic syndrome (VS)?
The main questions are:
Do women with VS exhibit...
- a different basal metabolic rate
- a reduced choroidal blood flow
- a reduced increase of oxygen consumption after intake of ice-water
- a different oxygen consumption after melatonin intake
- a different choroidal blood flow after melatonin intake
- a different oxygen consumption after melatonin intake and after intake of ice-water....?
详细描述
Study description:
Melatonin, a natural hormone of the pineal gland exclusively released during the dark phase, exhibits vasodilatatory effects in distal skin regions and reduces core body temperature. This study investigates whether exogenous melatonin (5mg p.o. at 2p.m.) in the afternoon, when no endogenous melatonin is secreted, increases not only distal skin blood flow, but also choroidal blood flow and changes oxygen consumption. Two subject groups were studied, women with vasospastic syndrome (VS) and controls. The main hypothesis is: melatonin normalizes distal vasoconstriction in VS.
Further questions will also be answered:
Does melatonin affect basal metabolic rate, increase choroidal blood flow and reduce the vasospastic syndrome (VS)?
Do women with VS exhibit:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •vasospastic syndrome
排除标准
- •BMI >25 or <18
- •drug intake
研究组 & 干预措施
A, 1
A, 1 = Melatonin
干预措施: Melatonin (Drug)
A, 2
A,2 = Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
-choroidal blood flow -oxygen consumption -Co2 production -skin temperatures -rectal temperatures -blood pressure -eye tension
时间窗: continously or 2-5 times
次要结局
未报告次要终点