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| Descriptive Information Fields | |||||||||
| Brief Title † | A Comparison of Two Caloric Supplements in the Prevention of Weight Loss in Patients With AIDS Who Take Daily Multivitamin and Mineral Supplements | ||||||||
| Official Title † | An Open-Label, Randomized, Three-Arm, Comparative Trial of a Caloric Supplement With Peptides and Medium-Chain Triglycerides Versus a Caloric Supplement With Whole Protein and Long-Chain Triglycerides Versus No Caloric Supplement for the Prevention of Weight Loss in Individuals With AIDS Who Take a Daily Multivitamin and Mineral Supplement | ||||||||
| 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. |
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| 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. |
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| Study Phase | |||||||||
| Study Type † | Observational | ||||||||
| Study Design † | Cohort, Prospective | ||||||||
| Primary Outcome Measure † | |||||||||
| Secondary Outcome Measure † | |||||||||
| Condition † | HIV Infections HIV Wasting Syndrome |
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| Intervention † | Dietary Supplement: Multivitamin and mineral supplements Dietary Supplement: Peptamen Dietary Supplement: NuBasics |
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| MEDLINE PMIDs | 9625392, 10770345 | ||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Active, not recruiting | ||||||||
| Enrollment † | 536 | ||||||||
| Start Date † | June 1996 | ||||||||
| Completion Date | |||||||||
| Eligibility Criteria † | Inclusion Criteria Patients must have:
Exclusion Criteria Co-existing Condition: Patients with any of the following symptoms or conditions are excluded:
Concurrent Medication: Excluded:
NOTE:
Patients with the following prior condition are excluded:
Prior Medication: Excluded within the past 2 weeks:
Excluded within the past 30 days:
NOTE:
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| Gender | Both | ||||||||
| Ages | 13 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00001077 | ||||||||
| Organization ID | CPCRA 038 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
| Verification Date | September 2008 | ||||||||
| First Received Date † | November 2, 1999 | ||||||||
| Last Updated Date | September 25, 2008 | ||||||||