Dose-response Enteral Citrulline for Normal Healthy Volunteers and Surgery Patients
Clinical Trial of Enteral Citrulline in Volunteers With Surgical Repair of Ventral Hernias
1 other identifier
interventional
14
1 country
1
Brief Summary
To determine the level of citrulline to produce a given amount of arginine in healthy volunteers and surgical patients. Arginine-related amino acids are expected to increase as a result of increased substrate provided by citrulline.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 10, 2009
CompletedFirst Posted
Study publicly available on registry
August 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedApril 25, 2012
April 1, 2012
2.1 years
July 10, 2009
April 24, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Plasma amino acid levels
8 hours
Study Arms (2)
Citrulline
EXPERIMENTALlemonade
PLACEBO COMPARATOREqual volume and flavor to citrulline.
Interventions
Eligibility Criteria
You may qualify if:
- adults, male \& female, non-pregnant
- BMI 18.5-29.9
You may not qualify if:
- cancer
- HIV positive
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juan B. Ochoa, MD Prof.
Associate Professor of Surgery and Critical Care, University of Pittsburgh Physicians
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2009
First Posted
August 3, 2009
Study Start
March 1, 2008
Primary Completion
April 1, 2010
Study Completion
August 1, 2010
Last Updated
April 25, 2012
Record last verified: 2012-04