NCT00675181

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….?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

September 11, 2012

Status Verified

September 1, 2012

Enrollment Period

1.7 years

First QC Date

May 6, 2008

Last Update Submit

September 10, 2012

Conditions

Vasospastic Syndrome

Keywords

melatoninskin blood flowchoroidal blood flowvasospastic subjectsnormal subjects

Outcome Measures

Primary Outcomes (1)

  • -choroidal blood flow -oxygen consumption -Co2 production -skin temperatures -rectal temperatures -blood pressure -eye tension

    continously or 2-5 times

Study Arms (2)

A, 1

ACTIVE COMPARATOR

A, 1 = Melatonin

Drug: Melatonin

A, 2

PLACEBO COMPARATOR

A,2 = Placebo

Drug: Placebo

Interventions

MelatoninDRUG

5mg per os

A, 1
PlaceboDRUG

per os

A, 2

Eligibility Criteria

Age20 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • vasospastic syndrome
  • healthy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Eye Clinic

Basel, 4031, Switzerland

Location

MeSH Terms

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Selim Orguel, MD

    University Eye Clinic, Basel, Switzerland

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2008

First Posted

May 8, 2008

Study Start

May 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

September 11, 2012

Record last verified: 2012-09

Locations

CH(1)