Vasospastic SyndromeMelO2NCT00675181
Effects of Melatonin and Oxygen Consumption and Choroidal Blood Flow
A study testing Melatonin in people with Vasospastic Syndrome, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 20 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vasospastic Syndrome
- What is being tested?
- Melatonin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2008to Jan 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- vasospastic syndrome
- healthy
Who cannot join
- sick
- BMI >25 or <18
- migraine
- drug intake
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Melatonin on Oxygen Consumption and Choroidal Blood Flow in Women With Vasospastic Syndrome in Comparison to Controls
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….?
Read the 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....?
- Conditions
- Vasospastic Syndrome
- Being tested
- Melatonin, Placebo
- Keywords
- melatonin, skin blood flow, choroidal blood flow, vasospastic subjects, normal subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
5mg per os
PlaceboDrug
per os
| Study group | Role | What they receive |
|---|---|---|
| A, 1 | Active comparator | A, 1 = Melatonin Receives: Drug: Melatonin |
| A, 2 | Placebo comparator | A,2 = Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
-choroidal blood flow -oxygen consumption -Co2 production -skin temperatures -rectal temperatures -blood pressure -eye tension
Measured: continously or 2-5 times
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2008 (estimated)
- Study startMay 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasospastic SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Selim Orguel, MD, Study director, University Eye Clinic, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675181
- Sponsor's protocol ID
- 087-KRK-2008-002
- Acronym
- MelO2
- Status last verified
- Sep 2012
- First submitted
- 6 May 2008
- Last updated
- 11 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Melatonin on Oxygen Consumption and Choroidal Blood Flow in Women With Vasospastic Syndrome in Comparison to Controls
- ClinicalTrials.gov ID
- NCT00675181
- Acronym / sponsor ID
- MelO2 / 087-KRK-2008-002
- Conditions
- Vasospastic Syndrome
- Keywords
- melatonin, skin blood flow, choroidal blood flow, vasospastic subjects, normal subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 8 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A, 1 | Active comparator | Drug: MelatoninA, 1 = Melatonin |
| A, 2 | Placebo comparator | Drug: PlaceboA,2 = Placebo |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- vasospastic syndrome
- healthy
Key exclusion criteria (4 listed)
- sick
- BMI >25 or <18
- migraine
- drug intake
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin5mg per os | Drug | A, 1 |
| Placeboper os | Drug | A, 2 |
Primary outcome
-choroidal blood flow -oxygen consumption -Co2 production -skin temperatures -rectal temperatures -blood pressure -eye tension
Time frame: continously or 2-5 times
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2012.
Related trials for Vasospastic Syndrome
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The DISCOVER INOCA Prospective Multi-center Registry
Ischemia and No Obstructive Coronary Artery Disease, Coronary Microvascular Dysfunction
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Noninvasive CA Monitoring Validation and Autonomic Modulation in Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal, Delayed Cerebral Ischemia
Not yet recruitingPhase 4
Lumbar Drain With Intrathecal Nicardipine in Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Hemorrhage
Recruiting
The Effect of Transcutaneous Vagal Nerve Stimulation (tVNS) on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid Hemorrhage
Aneurysmal Subarachnoid Hemorrhage, Vasospasm, Cerebral
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selim Orguel, MD study director
University Eye Clinic, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin in people with Vasospastic Syndrome, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
-choroidal blood flow -oxygen consumption -Co2 production -skin temperatures -rectal temperatures -blood pressure -eye tension (time frame: continously or 2-5 times). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2012.