Effects of Melatonin and Oxygen Consumption and Choroidal Blood Flow

Not Applicable

Completed

• Conditions: Vasospastic Syndrome
• Interventions: Drug: Placebo; Drug: Melatonin

• Registration Number: NCT00675181
• Lead Sponsor: University Hospital, Basel, Switzerland

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 Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-06
• Study First Submitted QC: 2008-05-07
• Study First Posted: 2008-05-08
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-10
• Last Update Posted: 2012-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 16

Inclusion Criteria

• vasospastic syndrome
• healthy

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A, 2	Placebo	A,2 = Placebo
A, 1	Melatonin	A, 1 = Melatonin

Primary Outcome Measures

Name	Time	Method
-choroidal blood flow -oxygen consumption -Co2 production -skin temperatures -rectal temperatures -blood pressure -eye tension	continously or 2-5 times

Trial Locations

Locations (1)

University Eye Clinic; 🇨🇭 Basel, Switzerland