Status:
COMPLETED
Nitric Oxide Supplementation in Argininosuccinic Aciduria
Lead Sponsor:
Baylor College of Medicine
Conditions:
Argininosuccinic Aciduria
Argininosuccinate Lyase Deficiency
Eligibility:
All Genders
8-64 years
Phase:
NA
Brief Summary
This is a study involving a dietary supplement. Patients with argininosuccinic aciduria will be randomly assigned to receive either a nitric oxide dietary supplement or placebo for 2 weeks, and then c...
Detailed Description
The investigators will perform a double blind, randomized, placebo-controlled, crossover study of NO supplementation in ASA patients assessing endothelial function and blood pressure as primary endpoi...
Eligibility Criteria
Inclusion
- A confirmed diagnosis of ASA based on biochemical, enzymatic, or genetic testing
- Capable of completing study procedures
- History of compliance with diet and treatment
Exclusion
- An active infection (viral or bacterial), any condition(s) that may precipitate a metabolic decompensation
- A hypersensitivity to nitrite
- A serum creatinine \> 1.5 times above the normal
- A clinical or laboratory abnormality of Grade 3 or greater according to the CTCAE V4.0 (except elevations of AST or ALT which are a part of the disease) which in the view of the Investigator compromises safety
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2018
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02252770
Start Date
September 1 2014
End Date
May 1 2018
Last Update
January 18 2020
Active Locations (1)
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1
Texas Children's Hospital
Houston, Texas, United States, 77030