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

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ClinicalTrials.gov Identifier: NCT00001077
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : October 1, 2013
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Tracking Information
First Submitted Date November 2, 1999
First Posted Date August 31, 2001
Last Update Posted Date October 1, 2013
Study Start Date June 1996
Actual Primary Completion Date April 1998   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00001077 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood collection
Sampling Method Non-Probability Sample
Study Population HIV-infected participants who take a daily multivitamin and mineral supplement
Condition
  • HIV Infections
  • HIV Wasting Syndrome
Intervention
  • Dietary Supplement: Multivitamin and mineral supplements
    Oral tablets taken daily
  • Dietary Supplement: Peptamen
    Solution received daily
  • Dietary Supplement: NuBasics
    Solution or dietary bar received daily
Study Groups/Cohorts
  • 1
    Participants will receive peptamen drinks and multivitamin and mineral supplements, taken in addition to a regular diet for 4 months
    Interventions:
    • Dietary Supplement: Multivitamin and mineral supplements
    • Dietary Supplement: Peptamen
  • 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
    Interventions:
    • Dietary Supplement: Multivitamin and mineral supplements
    • Dietary Supplement: NuBasics
  • 3
    Participants will receive multivitamin and mineral supplements, taken in addition to a regular diet for 4 months
    Intervention: Dietary Supplement: Multivitamin and mineral supplements
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 25, 2008)
536
Original Enrollment
 (submitted: June 23, 2005)
684
Actual Study Completion Date April 1998
Actual Primary Completion Date April 1998   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00001077
Other Study ID Numbers CPCRA 038
11588 ( Registry Identifier: DAIDS ES )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institute of Allergy and Infectious Diseases (NIAID)
Study Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators Not Provided
Investigators
Study Chair: Gilbert CL
Study Chair: Wheeler D
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date September 2013