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

Sponsor

Shahid Beheshti University of Medical Sciences (Other)

Overall Status

Unknown status

CT.gov ID

NCT02638727

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

14.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Vascular Disease	Drug: L-Citrulline Drug: placebo	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Assessment of Short-term Effect of L-Citrulline on Endothelial Function and Vasodilation in Known CAD Patients:A Randomized Crossover Clinical Trial

Study Start Date :

Dec 1, 2015

Anticipated Primary Completion Date :

Feb 1, 2016

Anticipated Study Completion Date :

Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Drug Arm This group treat with L-Citrulline (3 grams per day)	Drug: L-Citrulline This group treat with L-Citrulline (3 grams per day)
Placebo Comparator: Placebo Arm this group treat with placebi every day	Drug: placebo This group treat with placebo dayley

Arm

Intervention/Treatment

Active Comparator: Drug Arm

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

Drug: L-Citrulline

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

Placebo Comparator: Placebo Arm

this group treat with placebi every day

Drug: placebo

This group treat with placebo dayley

Outcome Measures

Primary Outcome Measures

improvement of flow mediated dilation to nitroglycerin dependent vasodilation [15 days]
improvement of FMD to NMD ratio (before L-Citrulline prescription) to FMD to NMD ratio (after L-Citrulline prescription)

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shahid Modaress Hospital , Tehran, Iran	Tehran		Iran, Islamic Republic of

Sponsors and Collaborators

Shahid Beheshti University of Medical Sciences

Investigators

Study Director: Morteza Safi, MD, Cardiovascular Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohammad Ali Akbarzadeh, sistant proffesor of shahid beheshti university of medical sciences, Shahid Beheshti University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT02638727

Other Study ID Numbers:

CVRC101

First Posted:

Dec 23, 2015

Last Update Posted:

Dec 23, 2015

Last Verified:

Dec 1, 2015

Keywords provided by Mohammad Ali Akbarzadeh, sistant proffesor of shahid beheshti university of medical sciences, Shahid Beheshti University of Medical Sciences

vascular disease

endothelial function

L-Citrulline

Additional relevant MeSH terms:

Vascular Diseases

Study Results

No Results Posted as of Dec 23, 2015