Lycopene Following Aneurysmal Subarachnoid Haemorrhage

NCT ID: NCT00905931

Last Updated: 2010-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-10-31

Brief Summary

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In this study the investigators wish to explore the potential neuroprotective effects of acute oral supplementation of lycopene, a natural anti-oxidant derived from tomatoes, on cerebral vasospasm and autoregulation, and examine whether any improvements translate into a reduction of biochemical markers of vascular injury and inflammation a decrease in the prevalence of secondary strokes following subarachnoid haemorrhage.

Detailed Description

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Conditions

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Subarachnoid Hemorrhage Aneurysm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active

Group Type EXPERIMENTAL

Lycopene

Intervention Type DRUG

30 mg oral, daily, for 21 days

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

starch

Interventions

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Lycopene

30 mg oral, daily, for 21 days

Intervention Type DRUG

placebo

starch

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age: \> 18 years old,
* Confirmed aneurysmal subarachnoid hemorrhage (aSAH),
* Time from ictus \< 96 hours

Exclusion Criteria

* Age: \< 18 years old,
* Non-aneurysmal SAH,
* Time from ictus \> 96 hours,
* Severe carotid atherosclerotic disease (≥70%)
* High-dose statin therapy (\>80 mg/day fluvastatin; \>40 mg/day simvastatin; \>40 mg/day pravastatin; \>10 mg/day atorvastatin; \>10 mg/day rosuvastatin 28),
* Allergy or hypersensitivity to tomatoes and tomato products and history of any other significant atopy/allergy (e.g. soy, whey, lutein, lecithin)
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cambridge Theranostics Ltd

INDUSTRY

Sponsor Role collaborator

University of Cambridge

OTHER

Sponsor Role lead

Responsible Party

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Addenbrooke's Hospital

Principal Investigators

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Peter J Kirkpatrick, FRCS(SN)

Role: PRINCIPAL_INVESTIGATOR

Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge, Addenbrooke's Hospital, Hills Road, CB2 0QQ Cambridge, UK

Locations

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Addenbrooke's Hospital

Cambridge, Cambridgeshire, United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Karol P Budohoski, MD

Role: CONTACT

(0044)1223331763 ext. 72831763

Facility Contacts

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Peter J Kirkpatrick, FRCS(SN)

Role: primary

(0044)1223245151

Karol P Budohoski, MD

Role: backup

(0044)1223 331763

References

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Verghese M, Sunkara R, Shackelford L, Walker LT. Lycopene and cardiovascular diseases. In Preedy VR, Watson RR Ed. Lycopene: nutritional, medicinal and therapeutic properties. Science Publishers, New Hampshire, USA 2008.

Reference Type BACKGROUND

Other Identifiers

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LASH 3

Identifier Type: -

Identifier Source: org_study_id

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