Back to resultsAssessment of Short-term Effect of L-Citrulline on Endothelial Function and Vasodilation in Known CAD Patients
Primary Purpose
Vascular Disease
Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
L-Citrulline
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Vascular Disease focused on measuring vascular disease, endothelial function, L-Citrulline
Eligibility Criteria
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
Sites / Locations
- Shahid Modaress Hospital , Tehran, IranRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Drug Arm
Placebo Arm
Arm Description
This group treat with L-Citrulline (3 grams per day)
this group treat with placebi every day
Outcomes
Primary Outcome Measures
improvement of flow mediated dilation to nitroglycerin dependent vasodilation
improvement of FMD to NMD ratio (before L-Citrulline prescription) to FMD to NMD ratio (after L-Citrulline prescription)
Secondary Outcome Measures
Full Information
NCT ID
NCT02638727
First Posted
November 8, 2015
Last Updated
December 19, 2015
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02638727
Brief Title
Assessment of Short-term Effect of L-Citrulline on Endothelial Function and Vasodilation in Known CAD Patients
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 Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
February 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Disease
Keywords
vascular disease, endothelial function, L-Citrulline
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Drug Arm
Arm Type
Active Comparator
Arm Description
This group treat with L-Citrulline (3 grams per day)
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
this group treat with placebi every day
Intervention Type
Drug
Intervention Name(s)
L-Citrulline
Intervention Description
This group treat with L-Citrulline (3 grams per day)
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
This group treat with placebo dayley
Primary Outcome Measure Information:
Title
improvement of flow mediated dilation to nitroglycerin dependent vasodilation
Description
improvement of FMD to NMD ratio (before L-Citrulline prescription) to FMD to NMD ratio (after L-Citrulline prescription)
Time Frame
15 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isa Khaheshi, MD
Phone
00989125441637
Email
isa_khaheshi@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morteza Safi, MD
Organizational Affiliation
Cardiovascular Research Center
Official's Role
Study Director
Facility Information:
Facility Name
Shahid Modaress Hospital , Tehran, Iran
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isa Khaheshi, MD
Phone
00989125441637
Email
isa_khaheshi@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Assessment of Short-term Effect of L-Citrulline on Endothelial Function and Vasodilation in Known CAD Patients
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