Effects of Melatonin and Oxygen Consumption and Choroidal Blood Flow

Study Overview
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Brief Summary
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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….?

Detailed Description
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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: 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....?

Official Title
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Effects of Melatonin on Oxygen Consumption and Choroidal Blood Flow in Women With Vasospastic Syndrome in Comparison to Controls

Conditions
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Vasospastic Syndrome

Intervention / Treatment
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* Drug: Melatonin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: vasospastic syndrome healthy Exclusion Criteria: sick BMI >25 or <18 migraine drug intake

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A, 1<br>A, 1 = Melatonin | Drug: Melatonin<br>* 5mg per os<br>|
| Placebo Comparator: A, 2<br>A,2 = Placebo | Drug: Placebo<br>* per os<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| -choroidal blood flow -oxygen consumption -Co2 production -skin temperatures -rectal temperatures -blood pressure -eye tension |  | continously or 2-5 times | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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melatonin, skin blood flow, choroidal blood flow, vasospastic subjects, normal subjects