Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001077
Status:
COMPLETED
Last Update Posted:
2013-10-01
First Post:
1999-11-02
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
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11588 | REGISTRY | DAIDS ES | None |