Tolerance & Practicality of Module AOX

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00425529
Study type	Interventional
Source	VU University Medical Center
Contact
Status	Completed
Phase	Phase 0
Start date	February 2002
Completion date	May 2003

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Tolerance and Practicality of Module AOX

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms