Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00067132 · ClinicalTrials.gov registry record · Phase 1
Adjuvant Nutrition for Critically Ill Trauma Patients
A Phase 1 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
NCT00067132 is a Phase 1 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 100 participants.
The verdict
NCT00067132, a Phase 1 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
Study Summary
Of the four million trauma cases each year that will require hospitalization, 200,000 will be classified as severe trauma. During the hospital stay, malnutrition is a major complication in about 50% of the patient population. The result is muscle wasting which is a major risk factor for increased morbidity and mortality. In this study we postulate that supplementation with beta-hydroxy-beta-methylbutyrate (HMB), arginine and glutamine (HMB/Arg/Gln)or HMB alone to these severely traumatized patients can stem the loss of muscle tissue and whole body nitrogen and in turn decrease morbidity and mortality. This hypothesis is based on two recent studies showing the same nutritional mixture of HMB/Arg/Gln can reverse the muscle wasting associated with AIDS and Cancer. The hypermetabolic state seen in AIDS and cancer have a similar multifactorial etiology as seen in trauma. There is an increase in the mobilization of fat and muscle, increased or normal metabolic rate, increased protein breakdown, and an increased or normal glucose turnover. In addition, HMB alone has been shown to reduce nitrogen loss, decrease muscle proteolysis and muscle damage within the first 48 hours to three weeks after initiating supplementation during a strenuous exercise program. Male and female patients (n=100) will be recruited at the time of admittance to the Trauma ICU with an ISS of greater than 18. Patients who meet the inclusion/exclusion criteria will be randomized to receive either 1) standard tube feed plus HMB/Arg/Gln, 2) standard tube feed plus HMB alone, or 3)standard tube feed (control) in a double-blinded fashion. Clinical outcomes measures will be assessed through out the hospital stay and on an outpatient basis at weeks 4 and 12. Muscle proteolysis and nitrogen economy will be evaluated on daily basis while in the hospital and after 4 weeks on an out patient basis. If as expected, Phase I results confirm the effectiveness of the nutrient mixture in trauma patients, expanded multic
Interventions
- PROCEDURE Juven (nutritional), HMB (nutritional)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2003-03 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00067132
The ClinicalTrials.gov registry entry for NCT00067132 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Juven (nutritional), HMB (nutritional) is the first listed.
NCT00067132 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00067132 about?
NCT00067132 is a clinical study titled "Adjuvant Nutrition for Critically Ill Trauma Patients". Of the four million trauma cases each year that will require hospitalization, 200,000 will be classified as severe trauma. During the hospital stay, malnutrition is a major complication in about 50% of the patient population. The result is muscle wasting which is a major risk factor for increased mo...
What is the current status of trial NCT00067132?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2003-03.
What interventions are being tested in trial NCT00067132?
The interventions under investigation include: Juven (nutritional), HMB (nutritional) (PROCEDURE).
Who is sponsoring clinical trial NCT00067132?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.