Effects of Melatonin and Oxygen Consumption and Choroidal Blood Flow

Vasospastic Syndrome Clinical Trial

— MelO2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00675181
• Other study ID #: 087-KRK-2008-002
• Status: Completed
• Phase: N/A
• First received: May 6, 2008
• Last updated: September 10, 2012
• Start date: May 2008
• Est. completion date: January 2010

Study information

• Verified date: September 2012
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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….?

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....?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 30 Years

Eligibility

Inclusion Criteria:

• vasospastic syndrome

• healthy

Exclusion Criteria:

• sick

• BMI >25 or <18

• migraine

• drug intake

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Vasospastic Syndrome

Intervention

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

Locations

Country	Name	City	State
Switzerland	University Eye Clinic	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	-choroidal blood flow -oxygen consumption -Co2 production -skin temperatures -rectal temperatures -blood pressure -eye tension		continously or 2-5 times	No