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Assessment of Short-term Effect of L-Citrulline on Endothelial Function and Vasodilation in Known CAD Patients

NCT ID: NCT02638727

Last Updated: 2015-12-23

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

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-02-29

Brief Summary

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The purpose of this study is to determine the efficacy of oral L-Citrulline on endothelial function and vasodilation in patients with coronary artery disease(CAD) by evaluating the brachial artery diameter in the antecubital area by ultrasonography.

Detailed Description

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Before prescribing the drug or placebo, the patients were evaluated via the ultrasound machine equipped. The brachial artery diameter in the antecubital area was measured by the ultrasound and was recorded. Then blood pressure cuff was attached on the arm and dilated 50mmhg above the systolic pressure and for 5 minutes remained the same level to induce ischemia at distal tissues until the occurrence of compensatory vasodilatation. Then the brachial artery diameter (as an estimation of FMD) was measured and recorded. After 4 minutes of administration of 2 puffs of nitroglycerin spray, the brachial artery diameter (as an estimation of NMD) was measured.

After 15 days treatment with the L-Citrulline or the placebo, the patients underwent the ultrasonography again and the above assessments were done.

Improvement of FMD to NMD ratio (before L-Citrulline prescription) to FMD to NMD ratio (after L-Citrulline prescription) is determined as "improvement of flow mediated dilation to nitroglycerin dependent vasodilation" evaluate.

Conditions

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Vascular Disease

Keywords

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vascular disease endothelial function L-Citrulline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Drug Arm

This group treat with L-Citrulline (3 grams per day)

Group Type ACTIVE_COMPARATOR

L-Citrulline

Intervention Type DRUG

This group treat with L-Citrulline (3 grams per day)

Placebo Arm

this group treat with placebi every day

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

This group treat with placebo dayley

Interventions

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L-Citrulline

This group treat with L-Citrulline (3 grams per day)

Intervention Type DRUG

placebo

This group treat with placebo dayley

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* history of documented CAD; flow mediated dilation to nitroglycerin dependent vasodilation (FMD/NMD)ratio less than 1

Exclusion Criteria

* no documented CAD; flow mediated dilation to nitroglycerin dependent vasodilation (FMD/NMD)ratio equal /more than 1
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Mohammad Ali Akbarzadeh

sistant proffesor of shahid beheshti university of medical sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Morteza Safi, MD

Role: STUDY_DIRECTOR

Cardiovascular Research Center

Locations

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Shahid Modaress Hospital , Tehran, Iran

Tehran, , Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Isa Khaheshi, MD

Role: CONTACT

Phone: 00989125441637

Email: [email protected]

Facility Contacts

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Isa Khaheshi, MD

Role: primary

Other Identifiers

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CVRC101

Identifier Type: -

Identifier Source: org_study_id