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

September 10, 2012 updated by: University Hospital, Basel, Switzerland

Effects of Melatonin on Oxygen Consumption and Choroidal Blood Flow in Women With Vasospastic Syndrome in Comparison to Controls

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….?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • University Eye Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • vasospastic syndrome
  • healthy

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
-choroidal blood flow -oxygen consumption -Co2 production -skin temperatures -rectal temperatures -blood pressure -eye tension
Time Frame: continously or 2-5 times
continously or 2-5 times

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

May 6, 2008

First Submitted That Met QC Criteria

May 7, 2008

First Posted (Estimate)

May 8, 2008

Study Record Updates

Last Update Posted (Estimate)

September 11, 2012

Last Update Submitted That Met QC Criteria

September 10, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 087-KRK-2008-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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