NCT03911089

A Collection of Case Studies in Infants With UCD to Evaluate Infant Growth and the Safety of a New Medical Food for UCD

A Collection of Case Studies in Infants With Urea Cycle Disorders (UCD) to Evaluate Infant Growth and the Safety of a New Medical Food for UCD

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Nutricia Research · Industry
• Sex: All
• Age: 30 Days
• Healthy volunteers: Not accepted

Summary

Original study: Study aims to enroll 3-5 children with confirmed Urinary Cycle Disorder (UCD). Subjects meeting the inclusion and exclusion criteria are included during the baseline visit. All subjects will receive the investigational product for a period of 16 weeks. At baseline, 2, 4, 8, 12 and 16 weeks the study parameters are assessed. The study amendment aims to collect case studies retrospectively of children who have used UCD Anamix Infant for at least 16 weeks, in countries where UCD Anamix Infant is already available on the market. It is aimed to collect the same study parameters of the original study at preferably the same timepoints.

Conditions

• Urea Cycle Disorder
• Inborn Errors of Metabolism

Interventions

Type	Name	Description
OTHER	UCD Anamix Infant	UCD Anamix infant with DHA and ARA is an amino acid based infant medical food containing only the essential amino acids, carbohydrate, fat, vitamins, minerals and trace elements.

Timeline

• Start date: 2013-05-28
• Primary completion: 2019-11-01
• Completion: 2019-11-01
• First posted: 2019-04-10
• Last updated: 2021-12-09

Locations

1 site across 1 country: United States