NCT00425529

Tolerance and Practicality of Module AOX

Tolerance and Practicality of Module AOX - a Modular Device for Supplementation of Enteral Nutrition

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (planned)
• Sponsor: Amsterdam UMC, location VUmc · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this clinical trial is to test the tolerance and practicality of the new device Module AOX. The secondary objective is to determine the changes in oxidative, antioxidative status, plasma free amino acids, and various immune parameters in critically ill patients receiving the enteral nutrition with and without using Module AOX.

Detailed description

Surgery and trauma induce hypercatabolism accompanied by a systemic immunoinflammtory response and massive production of reactive oxygen species at the site of injury. In these situations, requirements for certain amino acids (glutamine, cysteine) and antioxidant micronutrients (zinc, vitamin E, vitamin C, beta-caroteen, selenium) are markedly increased and may not be covered by the levels normally present in standard enteral diets, especially in the early phase when enteral nutrition is introduced gradually. Thus, supplementation with amino acids and antioxidant micronutrients may be appropiate in order to optimize nutritional support in such patients. The administration of selected nutrients via modular devices added to a standard enteral formulation is an attractive means of providing optimized nutrition support for specific disease states. Module AOX is intended for supplementation of patients requiring nutritional support for a condition in which oxidative stress is expected. The module contains: * Glutamine: to support gut mucosal and immune function, to minimize early depletion of glutamine stores and preserve body protein * Cysteine: to support synthesis of glutathione, an important cellular antioxidant, and to support the synthesis of acute phase proteins * Vitamin E, vitamin C and beta-caroteen: water- and lipid-soluble antioxidant micronutrients to boost antioxidant defenses * Zinc: to compensate for increased losses and to support protein synthesis, immune function and wound healing * Selenium: to compensate for increased losses, support antioxidant defenses and immune function

Conditions

• Gastrointestinal Diseases
• Nutrition

Interventions

Type	Name	Description
DEVICE	Module AOX (attached to Sondalis ISO)

Timeline

• Start date: 2002-02-01
• Completion: 2003-05-01
• First posted: 2007-01-23
• Last updated: 2007-01-23

Locations

1 site across 1 country: Netherlands