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

September 28, 2013 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

536

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94110
        • Community Consortium / UCSF
    • Colorado
      • Denver, Colorado, United States, 80204
        • Denver CPCRA / Denver Public Hlth
    • District of Columbia
      • Washington, District of Columbia, United States, 20422
        • Washington Reg AIDS Prog / Dept of Infect Dis
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • AIDS Research Consortium of Atlanta
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush Presbyterian - Saint Luke's Med Ctr
      • Chicago, Illinois, United States, 60657
        • AIDS Research Alliance - Chicago
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Baltimore Trials
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hosp
      • Detroit, Michigan, United States, 48201
        • Wayne State Univ / WSU / DMC HIV / AIDS Program
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Southern New Jersey AIDS Cln Trials / Dept of Med
      • Newark, New Jersey, United States, 07103
        • North Jersey Community Research Initiative
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Partners Research
      • Albuquerque, New Mexico, United States, 87131
        • Partners in Research - New Mexico
    • New York
      • New York, New York, United States, 10037
        • Harlem AIDS Treatment Group / Harlem Hosp Ctr
    • Oregon
      • Portland, Oregon, United States, 97210
        • Portland Veterans Adm Med Ctr / Rsch & Education Grp
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Philadelphia FIGHT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

HIV-infected participants who take a daily multivitamin and mineral supplement

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: Gilbert CL
  • Study Chair: Wheeler D

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1996

Primary Completion (Actual)

April 1, 1998

Study Completion (Actual)

April 1, 1998

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

October 1, 2013

Last Update Submitted That Met QC Criteria

September 28, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPCRA 038
  • 11588 (Registry Identifier: DAIDS ES)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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