A Comparison of Two Caloric Supplements in the Prevention of Weight Loss in Patients With AIDS Who Take Daily Multivitamin and Mineral Supplements
- Conditions
- HIV InfectionsHIV Wasting Syndrome
- Interventions
- Dietary Supplement: Multivitamin and mineral supplementsDietary Supplement: PeptamenDietary Supplement: NuBasics
- Registration Number
- NCT00001077
- Brief Summary
To compare a caloric supplement containing peptides and medium-chain triglycerides, a caloric supplement containing whole protein and long-chain triglycerides, and no caloric supplement for the prevention of weight loss in individuals with AIDS who take a daily multivitamin and mineral supplement.
- Detailed Description
Patients will be randomized to one of 3 study arms:
Arm 1 - Peptamen drinks + multivitamin and mineral supplement, taken in addition to regular diet for 4 months Arm 2 - NuBasics drinks or equivalent amounts of NuBasics soups or bars + multivitamin and mineral supplement, taken in addition to regular diet for 4 months Arm 3 - Multivitamin and mineral supplement, taken in addition to regular diet for 4 months.
At months 0, 2, and 4, patients will be assessed for weight, body cell mass, patient-reported physical activity level, and dietary intake (by 24-hour dietary recall). At months 2 and 4, they will also be assessed for compliance with study regimen. Patients who complete their 4 month follow up visit will be provided with a 30 day supply of the caloric supplement of their choice (Peptamen or NuBasics) and a 30 day supply of the study multivitamin supplement.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 536
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1 Multivitamin and mineral supplements Participants will receive peptamen drinks and multivitamin and mineral supplements, taken in addition to a regular diet for 4 months 1 Peptamen Participants will receive peptamen drinks and multivitamin and mineral supplements, taken in addition to a regular diet for 4 months 2 NuBasics Participants will receive NuBasics drinks or equivalent amounts of NuBasics soups or bars and daily multivitamin and mineral supplements, taken in addition to a regular diet for 4 months 3 Multivitamin and mineral supplements Participants will receive multivitamin and mineral supplements, taken in addition to a regular diet for 4 months 2 Multivitamin and mineral supplements Participants will receive NuBasics drinks or equivalent amounts of NuBasics soups or bars and daily multivitamin and mineral supplements, taken in addition to a regular diet for 4 months
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (17)
AIDS Research Alliance - Chicago
🇺🇸Chicago, Illinois, United States
Baltimore Trials
🇺🇸Baltimore, Maryland, United States
North Jersey Community Research Initiative
🇺🇸Newark, New Jersey, United States
Philadelphia FIGHT
🇺🇸Philadelphia, Pennsylvania, United States
Washington Reg AIDS Prog / Dept of Infect Dis
🇺🇸Washington, District of Columbia, United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr
🇺🇸New York, New York, United States
Community Consortium / UCSF
🇺🇸San Francisco, California, United States
Partners Research
🇺🇸Albuquerque, New Mexico, United States
Rush Presbyterian - Saint Luke's Med Ctr
🇺🇸Chicago, Illinois, United States
Denver CPCRA / Denver Public Hlth
🇺🇸Denver, Colorado, United States
Henry Ford Hosp
🇺🇸Detroit, Michigan, United States
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
🇺🇸Portland, Oregon, United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
🇺🇸New Orleans, Louisiana, United States
Wayne State Univ / WSU / DMC HIV / AIDS Program
🇺🇸Detroit, Michigan, United States
Southern New Jersey AIDS Cln Trials / Dept of Med
🇺🇸Camden, New Jersey, United States
Partners in Research - New Mexico
🇺🇸Albuquerque, New Mexico, United States