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Effects of Melatonin and Oxygen Consumption and Choroidal Blood Flow

NCT ID: NCT00675181

Last Updated: 2012-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-01-31

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....?

Conditions

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Vasospastic Syndrome

Keywords

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melatonin skin blood flow choroidal blood flow vasospastic subjects normal subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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A, 1

A, 1 = Melatonin

Group Type ACTIVE_COMPARATOR

Melatonin

Intervention Type DRUG

5mg per os

A, 2

A,2 = Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

per os

Interventions

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Melatonin

5mg per os

Intervention Type DRUG

Placebo

per os

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* vasospastic syndrome
* healthy

Exclusion Criteria

* sick
* BMI \>25 or \<18
* migraine
* drug intake
Minimum Eligible Age

20 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Selim Orguel, MD

Role: STUDY_DIRECTOR

University Eye Clinic, Basel, Switzerland

Locations

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University Eye Clinic

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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087-KRK-2008-002

Identifier Type: -

Identifier Source: org_study_id