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Nitric Oxide Supplementation on Neurocognitive Functions in Patients With ASLD

NCT03064048 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-02-27

No results posted yet for this study

Summary

This is a study involving a dietary supplement. Patients with argininosuccinate lyase deficiency (ASLD) will be randomly assigned to receive either a nitric oxide dietary supplement or placebo for 24 weeks, and then crossed-over to receive the other treatment for 24 weeks. The investigators will assess the effects of the supplement in domains of general cognition, memory, executive functioning, and fine motor functioning in individuals with ASLD.

Conditions

  • Argininosuccinate Lyase Deficiency
  • Urea Cycle Disorder
  • Urea Cycle Disorders, Inborn
  • Argininosuccinic Aciduria

Interventions

DIETARY_SUPPLEMENT

Neo-ASA

Dietary supplement with nitric oxide in the form of a lozenge called Neo-ASA.

DIETARY_SUPPLEMENT

Placebo

Dietary supplement with no nitric oxide in the form of a lozenge to look and taste like the dietary supplement Neo-ASA

Sponsors & Collaborators

  • Rare Diseases Clinical Research Network

    collaborator NETWORK

  • Neogenis Laboratories

    collaborator OTHER

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Sandesh C Nagamani, M.D. · Baylor College of Medicine

  • Brendan Lee, M.D., PhD · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-15
Primary Completion
2023-01-31
Completion
2023-01-31

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 NCT03064048 on ClinicalTrials.gov