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Completed

NCT Number: NCT00675181

Effects of Melatonin and Oxygen Consumption and Choroidal Blood Flow

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….?

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Key information

Conditions

Vasospastic Syndrome

Age range

20 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Eye Clinic

Basel, 4031, Switzerland

About this study

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....?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • vasospastic syndrome
  • healthy

Exclusion criteria

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

Treatment and study plan

Melatonin

Drug

5mg per os

Placebo

Drug

per os

Primary outcomes

  1. -choroidal blood flow -oxygen consumption -Co2 production -skin temperatures -rectal temperatures -blood pressure -eye tension

    Time frame: continously or 2-5 times

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: MelO2

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
May 8, 2008
Registry last updated
Sep 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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