Effect of Nitric Oxide (NO) Supplementation on Neurocognitive Measures in Argininosuccinate Lyase Deficiency (ASLD)

Status: Completed
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 50
Healthy Volunteers: f
View:

• Age \> 6 and \<50 years

• Diagnosis of ASLD confirmed by biochemical OR enzymatic OR genetic testing

• Has a history of compliance with diet and treatment

• Negative pregnancy test and ability to use birth control method for the entire duration of the study (if the subject is of child-bearing potential)

• Males who enroll in the study (and their partners) should argee to use an acceptable form of birth control for the entire duration of the study

Locations
United States
Texas
Baylor College of Medicine
Houston
Time Frame
Start Date: 2017-09-15
Completion Date: 2023-01-31
Participants
Target number of participants: 16
Treatments
Active_comparator: Neo-ASA
During this arm the participant will receive a lozenge with nitric oxide as a dietary supplement twice daily.
Placebo_comparator: Placebo
During this arm the participant will receive a lozenge which will not contain nitric oxide as a dietary supplement twice daily.
Authors
Sandesh C Nagamani, Brendan Lee
Sponsors
Collaborators: Neogenis Laboratories, Rare Diseases Clinical Research Network
Leads: Baylor College of Medicine

This content was sourced from clinicaltrials.gov

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