A Comparison of Two Caloric Supplements in the Prevention of Weight Loss in Patients With AIDS Who Take Daily Multivitamin and Mineral Supplements

National Institute of Allergy and Infectious Diseases (NIAID)

Status: Completed

Conditions: HIV Wasting Syndrome; HIV Infections

Treatments: Dietary Supplement: NuBasics; Dietary Supplement: Peptamen; Dietary Supplement: Multivitamin and mineral supplements

Study type: Observational

Funder types: NIH

Identifiers

NCT00001077

CPCRA 038

11588 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 536 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

536 participants in 3 patient groups

1

Description:

Participants will receive peptamen drinks and multivitamin and mineral supplements, taken in addition to a regular diet for 4 months

Treatment:

Dietary Supplement: Multivitamin and mineral supplements

Dietary Supplement: Peptamen

2

Description:

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

Treatment:

Dietary Supplement: Multivitamin and mineral supplements

Dietary Supplement: NuBasics

3

Description:

Participants will receive multivitamin and mineral supplements, taken in addition to a regular diet for 4 months

Treatment:

Dietary Supplement: Multivitamin and mineral supplements