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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
  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 (Subject, Caregiver, 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:


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 ]

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
Other Name: Melatonin
Placebo Comparator: A, 2
A,2 = Placebo
Drug: Placebo
per os
Other Name: Placebo

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
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

No publications provided

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
Health Authority: Switzerland: Swissmedic

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
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014