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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

University Hospital, Basel, Switzerland

ClinicalTrials.gov Identifier:

NCT00675181

First received: May 6, 2008

Last updated: September 10, 2012

Last verified: September 2012

History of Changes

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	Drug: Melatonin Drug: Placebo


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (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

Resource links provided by NLM:

MedlinePlus related topics: Oxygen Therapy

Drug Information available for: Melatonin

U.S. FDA Resources

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 ]


Enrollment:	16
Study Start Date:	May 2008
Study Completion Date:	January 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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


Responsible Party:	University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:	NCT00675181 History of Changes
Other Study ID Numbers:	087-KRK-2008-002
Study First Received:	May 6, 2008
Last Updated:	September 10, 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

ClinicalTrials.gov processed this record on July 24, 2017

To Top