Effects of Melatonin and Oxygen Consumption and Choroidal Blood Flow - Full Text View

Sponsored by:	University Hospital, Basel, Switzerland
Information provided by:	University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:	NCT00675181

Purpose

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	Intervention
Vasospastic Syndrome Healthy Subjects	Drug: Melatonin Drug: Placebo

Drug Information available for: Melatonin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment
Official Title:	Effects of Melatonin on Oxygen Consumption and Choroidal Blood Flow in Women With Vasospastic Syndrome in Comparison to Controls

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:

-choroidal blood flow -oxygen consumption -Co2 production -skin temperatures -rectal temperatures -blood pressure -eye tension [ Time Frame: continously or 2-5 times ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	April 2008
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A, 1: Active Comparator A, 1 = Melatonin	Drug: Melatonin 5mg per os
A, 2: Placebo Comparator A,2 = Placebo	Drug: Placebo per os

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....?

Eligibility

Ages Eligible for Study:	20 Years to 30 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675181

Contacts

Contact: Kurt Kraeuchi

41-61-325-5508

kurt.kraeuchi@upkbs.ch

Locations

Switzerland
University Eye Clinic	Recruiting
Basel, Switzerland, 4031
Contact: Kurt Kraeuchi 41-61-325-5508 kurt.kraeuchi@upkbs.ch

Sponsors and Collaborators

University Hospital, Basel, Switzerland

Investigators

Study Director:

Selim Orguel, MD

University Eye Clinic, Basel, Switzerland

More Information

Responsible Party:	University Hospital, Basel, Switzerland ( Selim Orguel, MD )
Study ID Numbers:	087-KRK-2008-002
Study First Received:	May 6, 2008
Last Updated:	May 7, 2008
ClinicalTrials.gov Identifier:	NCT00675181
Health Authority:	Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:

melatonin
skin blood flow
choroidal blood flow
vasospastic subjects
normal subjects

Study placed in the following topic categories:

Melatonin
Healthy

Additional relevant MeSH terms:

Antioxidants
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Syndrome

Physiological Effects of Drugs
Central Nervous System Depressants
Protective Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009