Clinical Trials Directory

Trials / Completed

CompletedNCT00006167

Nutrition Intervention in AIDS Wasting

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGoxandrolone
BEHAVIORALProgressive Resistance Training

Timeline

Start date
1998-01-01
Completion
2000-08-01
First posted
2000-08-09
Last updated
2010-01-13

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00006167. Inclusion in this directory is not an endorsement.