NCT00551434

Brief Summary

The study is a double blind 2x2 factorial study. Patients with coronary disease will be randomly be assigned to L-arginine (9 g/day), creatine 21 g/d, both, or neither dietary supplement. The function of the endothelium will be tested using ultrasound before and after each treatment. These studies will help us understand why the endothelium is abnormal in patients with coronary artery disease and how L-arginine is acting on endothelial function.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
119

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Aug 2002

Typical duration for not_applicable coronary-artery-disease

Status
completed

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

Study Start

First participant enrolled

August 1, 2002

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2007

Completed
Last Updated

October 31, 2007

Status Verified

October 1, 2007

First QC Date

October 30, 2007

Last Update Submit

October 30, 2007

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Brachial artery flow-mediated dilation

    5 days

Secondary Outcomes (1)

  • serum arginine, creatine, creatinine, homocysteine

    5 days

Study Arms (4)

1

EXPERIMENTAL
Dietary Supplement: Creatine

2

EXPERIMENTAL
Dietary Supplement: l-arginine

3

EXPERIMENTAL
Dietary Supplement: L-arginine and creatine

4

PLACEBO COMPARATOR
Dietary Supplement: placebo, double

Interventions

CreatineDIETARY_SUPPLEMENT

Creatine 21 g daily

1
L-arginine and creatineDIETARY_SUPPLEMENT

L-arginine

3
l-arginineDIETARY_SUPPLEMENT

l-arginine 9 g daily

2
placebo, doubleDIETARY_SUPPLEMENT

placebo

4

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Coronary artery disease

You may not qualify if:

  • Pregnancy
  • Creatine use within one month of study
  • L-arginine use within one month of study
  • Change in dose or initiation of lipid lowering therapy, aspirin therapy, or angiotensin converting enzyme therapy within one month of study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

CreatineArginine

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, BasicAmino Acids, DiaminoAmino Acids, Essential

Study Officials

  • Joseph A Vita, MD

    Boston Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 30, 2007

First Posted

October 31, 2007

Study Start

August 1, 2002

Study Completion

December 1, 2005

Last Updated

October 31, 2007

Record last verified: 2007-10