A Comparison of Two Caloric Supplements in the Prevention of Weight Loss in Patients With AIDS Who Take Daily Multivitamin and Mineral Supplements
This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00001077
First received: November 2, 1999
Last updated: December 18, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV Infections HIV Wasting Syndrome |
Dietary Supplement: Multivitamin and mineral supplements Dietary Supplement: Peptamen Dietary Supplement: NuBasics |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
Resource links provided by NLM:
Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):
Biospecimen Retention: Samples With DNA
Detailed Description:
Blood collection
| Enrollment: | 536 |
| Study Start Date: | June 1996 |
| Study Completion Date: | April 1998 |
| Primary Completion Date: | April 1998 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
Participants will receive peptamen drinks and multivitamin and mineral supplements, taken in addition to a regular diet for 4 months
|
Dietary Supplement: Multivitamin and mineral supplements
Oral tablets taken daily
Dietary Supplement: Peptamen
Solution received daily
|
|
2
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
|
Dietary Supplement: Multivitamin and mineral supplements
Oral tablets taken daily
Dietary Supplement: NuBasics
Solution or dietary bar received daily
|
|
3
Participants will receive multivitamin and mineral supplements, taken in addition to a regular diet for 4 months
|
Dietary Supplement: Multivitamin and mineral supplements
Oral tablets taken daily
|
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.
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
HIV-infected participants who take a daily multivitamin and mineral supplement
Criteria
Inclusion Criteria
Patients must have:
- HIV infection.
- Stable weight.
- CD4+ cell count <200 cells/mm3.
- Life expectancy of at least 6 months.
- Parent or legal guardian to sign written, informed consent for patients < 18 years old.
Exclusion Criteria
Co-existing Condition:
Patients with any of the following symptoms or conditions are excluded:
- Active opportunistic infection, requiring acute treatment.
- Malignancy (other than stable cutaneous Kaposi's sarcoma that does not require systemic chemotherapy).
- Diabetes mellitus or other conditions requiring special dietary restrictions.
- Body mass index (BMI) >= 29.0 kg/m2.
- Disorders or conditions that, in the treating clinician's opinion, may prevent adequate compliance with protocol requirements.
Concurrent Medication:
Excluded:
- Growth hormone.
- Megestrol acetate (Megace).
- Cyproheptadine (Periactin).
- Dronabinol (Marinol).
- Thalidomide.
- Anabolic steroids (e.g., nandrolone decanoate)(Deca-durabolin).
- Pharmacologic-dose corticosteroids (e.g., > 15 mg/day prednisone equivalent)
NOTE:
- Men requiring testosterone replacement therapy for documented hypogonadism may be enrolled.
- Caloric nutritional supplements deemed by the clinician to promote weight gain or maintenance.
Patients with the following prior condition are excluded:
- History of phenylketonuria.
Prior Medication:
Excluded within the past 2 weeks:
- Use of caloric nutritional supplements for more than 5 days deemed by the clinician to promote weight gain or maintenance.
Excluded within the past 30 days:
- Growth hormone.
- Megestrol acetate (Megace).
- Cyproheptadine (Periactin).
- Dronabinol (Marinol).
- Thalidomide.
- Anabolic steroids (e.g., nandrolone decanoate)(Deca-durabolin)
- Pharmacologic-dose corticosteroids (e.g., > 15 mg/day prednisone equivalent).
NOTE:
- Men requiring testosterone replacement therapy for documented hypogonadism may be enrolled.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001077
Locations
| United States, California | |
| Community Consortium / UCSF | |
| San Francisco, California, United States, 94110 | |
| United States, Colorado | |
| Denver CPCRA / Denver Public Hlth | |
| Denver, Colorado, United States, 802044507 | |
| United States, District of Columbia | |
| Washington Reg AIDS Prog / Dept of Infect Dis | |
| Washington, District of Columbia, United States, 20422 | |
| United States, Georgia | |
| AIDS Research Consortium of Atlanta | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Illinois | |
| Rush Presbyterian - Saint Luke's Med Ctr | |
| Chicago, Illinois, United States, 60612 | |
| AIDS Research Alliance - Chicago | |
| Chicago, Illinois, United States, 60657 | |
| United States, Louisiana | |
| Louisiana Comm AIDS Rsch Prog / Tulane Univ Med | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| Baltimore Trials | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Michigan | |
| Henry Ford Hosp | |
| Detroit, Michigan, United States, 48202 | |
| Wayne State Univ / WSU / DMC HIV / AIDS Program | |
| Detroit, Michigan, United States, 48201 | |
| United States, New Jersey | |
| Southern New Jersey AIDS Cln Trials / Dept of Med | |
| Camden, New Jersey, United States, 08103 | |
| North Jersey Community Research Initiative | |
| Newark, New Jersey, United States, 071032842 | |
| United States, New Mexico | |
| Partners Research | |
| Albuquerque, New Mexico, United States, 871315271 | |
| Partners in Research - New Mexico | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, New York | |
| Harlem AIDS Treatment Group / Harlem Hosp Ctr | |
| New York, New York, United States, 10037 | |
| United States, Oregon | |
| Portland Veterans Adm Med Ctr / Rsch & Education Grp | |
| Portland, Oregon, United States, 972109951 | |
| United States, Pennsylvania | |
| Philadelphia FIGHT | |
| Philadelphia, Pennsylvania, United States, 19107 | |
Sponsors and Collaborators
Investigators
| Study Chair: | Gilbert CL | |
| Study Chair: | Wheeler D |
More Information
Publications:
Gibert CL, Muurahainen N, Collins G, Williams B, Raghavan S, Bartsch G, Wheeler D. Body composition in HIV-infected men and women in 1996-1997 (CPCRA 038). Int Conf AIDS. 1998;12:554 (abstract no 32169)
Williams SB, Collins G, Muurahainen N, Bartsch G, Gibert C, Raghavan SS, Wheeler D. Protein intake is associated with body cell mass in weight-stable HIV+ men with CD4 < 200 cells/mm3: CPCRA 038. Int Conf AIDS. 1998;12:841-2 (abstract no 42339)
Muurahainen N, Collins G, Wheeler D, Mateo N, Madans M, Bartsch G, Gilbert C. Body cell mass (BCM) in HIV-infected (HIV+) males in the community programs for clinical research on AIDS (CPCRA) in 1996-1997. Int Conf AIDS. 1998;12:840 (abstract no 42333)
| Responsible Party: | Rona Siskind, DAIDS |
| ClinicalTrials.gov Identifier: | NCT00001077 History of Changes |
| Other Study ID Numbers: | CPCRA 038 |
| Study First Received: | November 2, 1999 |
| Last Updated: | December 18, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Weight Loss Acquired Immunodeficiency Syndrome Nutritional Support |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Wasting Syndrome Weight Loss HIV Wasting Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Metabolic Diseases Nutrition Disorders Body Weight Changes Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013