Effects of Melatonin and Oxygen Consumption and Choroidal Blood Flow (MelO2)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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….?

Condition or disease	Intervention/treatment	Phase
Vasospastic Syndrome	Drug: Melatonin; Drug: Placebo	Not Applicable

Detailed Description:

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....?

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	16 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Basic Science
Official Title:	Effects of Melatonin on Oxygen Consumption and Choroidal Blood Flow in Women With Vasospastic Syndrome in Comparison to Controls
Study Start Date :	May 2008
Actual Primary Completion Date :	January 2010
Actual Study Completion Date :	January 2010

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: A, 1; A, 1 = Melatonin	Drug: Melatonin; 5mg per os
Placebo Comparator: A, 2; A,2 = Placebo	Drug: Placebo; per os

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. -choroidal blood flow -oxygen consumption -Co2 production -skin temperatures -rectal temperatures -blood pressure -eye tension [ Time Frame: continously or 2-5 times ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	20 Years to 30 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• vasospastic syndrome
• healthy

Exclusion Criteria:

• sick
• BMI >25 or <18
• migraine
• drug intake

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Switzerland
University Eye Clinic
Basel, Switzerland, 4031

Sponsors and Collaborators

University Hospital, Basel, Switzerland

Investigators

Study Director:	Selim Orguel, MD	University Eye Clinic, Basel, Switzerland

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:	NCT00675181 History of Changes
Other Study ID Numbers:	087-KRK-2008-002
First Posted:	May 8, 2008
Last Update Posted:	September 11, 2012
Last Verified:	September 2012

Keywords provided by University Hospital, Basel, Switzerland:

melatonin; skin blood flow; choroidal blood flow; vasospastic subjects; normal subjects

Additional relevant MeSH terms:

Syndrome; Disease; Pathologic Processes; Melatonin; Antioxidants	Molecular Mechanisms of Pharmacological Action; Protective Agents; Physiological Effects of Drugs; Central Nervous System Depressants