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Nitric Oxide Supplementation in Argininosuccinic Aciduria

NCT02252770 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-01-18

No results posted yet for this study

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 crossed-over to receive the other treatment for two weeks.

The investigators expect to see that : 1) Patients with ASA will have a decreased ability for their arteries to dilate due to nitric oxide deficiency, 2) Treatment of ASA with the nitric oxide supplement will improve the ability of their arteries to dilate, and 3) Through the testing of subjects' fibroblasts (cells in connective tissue that produce collagen and other fibers), the investigators hope to predict which patients may respond NO supplementation.

Conditions

  • Argininosuccinic Aciduria
  • Argininosuccinate Lyase Deficiency
  • Urea Cycle Disorders

Interventions

DIETARY_SUPPLEMENT

Nitric oxide supplement

Each active comparator supplement is an all natural nitric oxide supplement. Subjects will take one lozenge twice a day.

DIETARY_SUPPLEMENT

Placebo

Placebo will not contain nitric oxide supplement.

Sponsors & Collaborators

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Sandesh CS Nagamani, MD, FACMG · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
8 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2018-05-31
Completion
2018-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02252770 on ClinicalTrials.gov