Effects of Melatonin and Oxygen Consumption and Choroidal... | NCT00675181

Studies
Effects of Melatonin and Oxygen Consumption and Choroidal Blood Flow

NCT00675181

Sponsor

University Hospital, Basel, Switzerland

Status

Completed

Last Update Posted

Sep 11, 2012Estimated

Enrollment

16Actual

Phase

Not Applicable

Conditions

Vasospastic Syndrome

Interventions

Melatonin
Placebo

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Jan 2010Actual

Completion Date

Jan 2010Actual

First Submitted Date

May 6, 2008

First Submission Date that Met QC Criteria

May 7, 2008

First Posted Date

May 8, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2012

Last Update Posted Date

Sep 11, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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....?

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A, 1	Active Comparator	A, 1 = Melatonin	Drug: Melatonin
A, 2	Placebo Comparator	A,2 = Placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Melatonin	Drug	5mg per os	A, 1
Placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

vasospastic syndrome
healthy

Exclusion Criteria:

sick
BMI >25 or <18
migraine
drug intake

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Selim Orguel, MD	University Eye Clinic, Basel, Switzerland	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Eye Clinic		Basel		4031	Switzerland

Intervention Browse Module

MeSH Terms

ID	Term
D008550	Melatonin

Ancestor Terms

ID	Term
D014363	Tryptamines
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided