Effects of Melatonin and Oxygen Consumption and Choroidal Blood Flow - Tabular View

Tracking Information

First Received Date ^ICMJE

May 6, 2008

Last Updated Date

November 17, 2009

Start Date ^ICMJE

May 2008

Estimated Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

-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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00675181 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Effects of Melatonin and Oxygen Consumption and Choroidal Blood Flow

Official Title ^ICMJE

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

Brief Summary

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….?

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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Vasospastic Syndrome
Healthy Subjects

Intervention ^ICMJE

Drug: Melatonin
Drug: Placebo

Study Arms / Comparison Groups

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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

October 2010

Estimated Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

vasospastic syndrome
healthy

Exclusion Criteria:

sick
BMI >25 or <18
migraine
drug intake

Gender

Female

Ages

20 Years to 30 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Kurt Kraeuchi

41-61-325-5508

kurt.kraeuchi@upkbs.ch

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT ID ^ICMJE

NCT00675181

Responsible Party

Selim Orguel, MD, University Hospital, Basel, Switzerland

Study ID Numbers ^ICMJE

087-KRK-2008-002

Study Sponsor ^ICMJE

University Hospital, Basel, Switzerland

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Selim Orguel, MD

University Eye Clinic, Basel, Switzerland

Information Provided By

University Hospital, Basel, Switzerland

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP