Official Title: “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 Type: Interventional

Study Design: Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment

Study Primary Completion Date: April 2010

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....?

Intervention(s) in this Clinical Trial

• Drug: Melatonin
  • 5mg per os
• Drug: Placebo
  • per os

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A, 1
  • A, 1 = Melatonin
• Placebo Comparator: A, 2
  • A,2 = Placebo

Primary Measures

• -choroidal blood flow -oxygen consumption -Co2 production -skin temperatures -rectal temperatures -blood pressure -eye tension
  • Time Frame: continously or 2-5 times
    Safety Issue?: No

Inclusion Criteria:

• vasospastic syndrome
• healthy

Exclusion Criteria:

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 30 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: University Hospital, Basel, Switzerland

Overall Clinical Trial Officials and Contacts

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

Overall Contact: Kurt Kraeuchi 41-61-325-5508 kurt.kraeuchi@upkbs.ch

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00675181

Study ID Number: 087-KRK-2008-002

ClinicalTrials.gov Identifier: NCT00675181

Health Authority: Switzerland: Swissmedic