Effects of Melatonin and Oxygen Consumption and Choroidal Blood Flow (MelO2)
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ClinicalTrials.gov Identifier: NCT00675181 |
Recruitment Status :
Completed
First Posted : May 8, 2008
Last Update Posted : September 11, 2012
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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 |
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 (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 |

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

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Ages Eligible for Study: | 20 Years to 30 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- vasospastic syndrome
- healthy
Exclusion Criteria:
- sick
- BMI >25 or <18
- migraine
- drug intake

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
Switzerland | |
University Eye Clinic | |
Basel, Switzerland, 4031 |
Study Director: | Selim Orguel, MD | University Eye Clinic, Basel, Switzerland |
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 |
melatonin skin blood flow choroidal blood flow vasospastic subjects normal subjects |
Syndrome Disease Pathologic Processes Melatonin Antioxidants |
Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Central Nervous System Depressants |