Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00675181
Recruitment Status : Completed
First Posted : May 8, 2008
Last Update Posted : September 11, 2012
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Study Description
Go to 
Top of Page 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy
Drug Information available for: Melatonin

Arms and Interventions
Go to 
Top of Page 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
Go to 
Top of Page 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00675181


Locations
Layout table for location information
Switzerland
University Eye Clinic
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Layout table for investigator information
Study Director: Selim Orguel, MD University Eye Clinic, Basel, Switzerland
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00675181    
Other Study ID Numbers: 087-KRK-2008-002
First Posted: May 8, 2008    Key Record Dates
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:
Layout table for MeSH terms
Syndrome
Disease
Pathologic Processes
Melatonin
Antioxidants
 Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants