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NCT00006167 · ClinicalTrials.gov registry record · Phase 4

Nutrition Intervention in AIDS Wasting

A Phase 4 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

Completed
Registry status
Phase 4
Development phase

NCT00006167 is a Phase 4 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

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The verdict

NCT00006167, a Phase 4 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

COMPLETED
Registry status
Phase 4
Development phase

Study Summary

There are no guidelines for appropriate nutritional management of weight loss or wasting in HIV infection. Some treatments may increase weight, but without improving muscle mass or quality of life. In this clinical trial AIDS patients with wasting are randomized to one of three nutritional strategies and studied over a 12-week period: 1) optimal oral nutrition with counseling and protein and calorie supplementation, and a placebo pill; 2) optimal oral nutrition with the oral androgen, oxandrolone at 20 mg daily; and 3) optimal oral nutrition with progressive resistance training (PRT). In all participants, dietary intervention is maximized by weekly personalized counseling to address individual issues and concerns. Two primary outcomes are assessed: thigh muscle mass and quality of life. Our findings can be used to develop guidelines for standards of nutritional care among AIDS patient with the wasting syndrome.

Interventions

  • BEHAVIORAL Progressive Resistance Training
  • DRUG oxandrolone

Trial Details

FieldValue
Start Date 1998-01
Est. Completion 2000-08
Phase Phase 4

What the Registry Record Tells You About NCT00006167

The ClinicalTrials.gov registry entry for NCT00006167 describes a study currently listed as completed, categorized as Phase 4. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. 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 2 interventions - of which Progressive Resistance Training is the first listed.

NCT00006167 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00006167 about?

NCT00006167 is a clinical study titled "Nutrition Intervention in AIDS Wasting". There are no guidelines for appropriate nutritional management of weight loss or wasting in HIV infection. Some treatments may increase weight, but without improving muscle mass or quality of life. In this clinical trial AIDS patients with wasting are randomized to one of three nutritional strategie...

What is the current status of trial NCT00006167?

This trial is currently completed. It is a Phase 4 study. The study started on 1998-01. Estimated completion is 2000-08.

What interventions are being tested in trial NCT00006167?

The interventions under investigation include: Progressive Resistance Training (BEHAVIORAL), oxandrolone (DRUG).

Who is sponsoring clinical trial NCT00006167?

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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