NCT02638727

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2015

Completed
23 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 23, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

December 23, 2015

Status Verified

December 1, 2015

Enrollment Period

2 months

First QC Date

November 8, 2015

Last Update Submit

December 19, 2015

Conditions

Vascular Disease

Keywords

vascular diseaseendothelial functionL-Citrulline

Outcome Measures

Primary Outcomes (1)

  • 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)

    15 days

Study Arms (2)

Drug Arm

ACTIVE COMPARATOR

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

Drug: L-Citrulline

Placebo Arm

PLACEBO COMPARATOR

this group treat with placebi every day

Drug: placebo

Interventions

L-CitrullineDRUG

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

Drug Arm
placeboDRUG

This group treat with placebo dayley

Placebo Arm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shahid Modaress Hospital , Tehran, Iran

Tehran, Iran

RECRUITING

MeSH Terms

Conditions

Vascular Diseases

Interventions

Citrulline

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, DiaminoAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Morteza Safi, MD

    Cardiovascular Research Center

    STUDY DIRECTOR

Central Study Contacts

Isa Khaheshi, MD

CONTACT

00989125441637isa_khaheshi@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
sistant proffesor of shahid beheshti university of medical sciences

Study Record Dates

First Submitted

November 8, 2015

First Posted

December 23, 2015

Study Start

December 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

December 23, 2015

Record last verified: 2015-12

Locations

IR(1)