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Nutritional Therapy Improves Dyslipidemia in HIV Infected Teenagers With Antiretroviral Treatment

Primary Purpose

Adolescent Behavior, Hiv, Dyslipidemias

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nutritional therapy
Control group
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Adolescent Behavior focused on measuring HIV / AIDS, Dyslipidemia, Adolescents, Nutritional Therapy

Eligibility Criteria

13 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed HIV infection with a positive result obtained by performing a screening test for anti-HIV-1 and anti-HIV-2 and at least one confirmatory test;
  • Being on antiretroviral therapy for at least three months prior to the start of the study;
  • Present current biochemical exams: Dyslipidemia, characterized by Total Cholesterol> 170mg / dL associated with: Triglycerides greater than or equal to LDL cholesterol ≥ 130 mg / dL;
  • Availability to participate in the nutritional intervention with a low fat diet.

Exclusion Criteria:

  • Pregnant women;
  • Patients with active opportunistic infections;
  • Cognitive deficits;
  • Diabetes mellitus;
  • Patients taking lipid-lowering drugs;
  • Patients who are unaware of their HIV diagnosis.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Nutritional therapy group

    Control group

    Arm Description

    The group nutritional therapy intervention was subjected to a protocol that included: nutritional counseling and weekly phone calls for 12 weeks.

    The control group received conventional care consisting of usual medical care. The control group was followed according to the ambulatory care routine, which consists of medical follow-up by the assistant team.

    Outcomes

    Primary Outcome Measures

    Blood plasma level of total cholesterol
    Total blood cholesterol level will be assessed by blood test

    Secondary Outcome Measures

    Food intake
    Food intake will be assessed a 24-hour reminder
    Nutritional status
    Will be assessed by body mass index
    Blood plasma level of triglycerides
    Triglycerides level will be assessed by blood test
    Blood plasma level of HDL cholesterol
    HDL cholesterol level will be assessed by blood test

    Full Information

    First Posted
    January 11, 2017
    Last Updated
    August 22, 2017
    Sponsor
    Hospital de Clinicas de Porto Alegre
    Collaborators
    Centro Universitario La Salle
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03021889
    Brief Title
    Nutritional Therapy Improves Dyslipidemia in HIV Infected Teenagers With Antiretroviral Treatment
    Official Title
    Nutritional Therapy Improves Dyslipidemia in HIV Infected Teenagers With Antiretroviral Treatment: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2015 (Actual)
    Primary Completion Date
    November 2015 (Actual)
    Study Completion Date
    November 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hospital de Clinicas de Porto Alegre
    Collaborators
    Centro Universitario La Salle

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Introduction: Prolonged use of antiretroviral therapy is associated with metabolic and bodily changes such as lipodystrophy, diabetes mellitus, insulin resistance and dyslipidemia latter being associated with a higher chance of cardiovascular events and death. Objective: To evaluate the effect of nutritional therapy in dyslipidemic adolescents living with HIV / AIDS in antiretroviral therapy. Method: This is a randomized clinical trial with young people 13-19 years in outpatient treatment in a general hospital to present dyslipidemia. The intervention group received nutritional counseling for 12 weeks and weekly flights to nutritional counseling. The control group received standard care consisting of medical care. Demographic, clinical, nutritional variables, food surveys and lipid profiles were collected at baseline and at the end of the study for both groups.
    Detailed Description
    This is a open randomized clinical trial. The participants were adolescents (13 to 19 years old) diagnosed with HIV / AIDS from the Pediatric Infectious Disease Outpatient Clinic - zone 4, from a tertiary care university hospital in the South Region in Brazil, along with their caregivers. Present Dyslipidemia, characterized by Total Cholesterol> 200mg / dL associated with:Triglycerides ≥ 150mg HDL cholesterol (male <40 mg / dL and female <50 mg / dL) LDL cholesterol ≥ 160 mg / dL. The clinical profile, immunological, virological, the biochemical parameters will be accessed by the patient's chart and the dietary parameters will be evaluated by means of 24-hour reminder instrument. The sample was calculated, using a software, from an alpha error of 5%, reliability power of 80%, to obtain detection difference and standard deviation for each of the group of 40, totaling 36 patients. The randomization will be performed through simple randomization in blocks of 2 patients generated by computer program, available at www.randomization.com. The intervention group received nutritional counseling for 12 weeks and weekly flights to nutritional counseling. The control group received standard care consisting of medical care. Demographic, clinical, nutritional variables, food surveys and lipid profiles were collected at baseline and at the end of the study for both groups.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adolescent Behavior, Hiv, Dyslipidemias
    Keywords
    HIV / AIDS, Dyslipidemia, Adolescents, Nutritional Therapy

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care Provider
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Nutritional therapy group
    Arm Type
    Experimental
    Arm Description
    The group nutritional therapy intervention was subjected to a protocol that included: nutritional counseling and weekly phone calls for 12 weeks.
    Arm Title
    Control group
    Arm Type
    Other
    Arm Description
    The control group received conventional care consisting of usual medical care. The control group was followed according to the ambulatory care routine, which consists of medical follow-up by the assistant team.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Nutritional therapy
    Intervention Description
    The nutritional therapy intervention group received monthly nutritional guidelines for 12 weeks focusing on the diet for dyslipidemia, based on the recommendation of the type I diet of the Clinical Protocol and Therapeutic Guidelines for Management of HIV Infection in children and adolescents. In addition, participants in the intervention group received weekly phone calls for nutritional counseling.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Control group
    Intervention Description
    The control group was followed according to the ambulatory care routine, which consists of medical follow-up by the assistant team.
    Primary Outcome Measure Information:
    Title
    Blood plasma level of total cholesterol
    Description
    Total blood cholesterol level will be assessed by blood test
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Food intake
    Description
    Food intake will be assessed a 24-hour reminder
    Time Frame
    12 months
    Title
    Nutritional status
    Description
    Will be assessed by body mass index
    Time Frame
    12 months
    Title
    Blood plasma level of triglycerides
    Description
    Triglycerides level will be assessed by blood test
    Time Frame
    12 months
    Title
    Blood plasma level of HDL cholesterol
    Description
    HDL cholesterol level will be assessed by blood test
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    13 Years
    Maximum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosed HIV infection with a positive result obtained by performing a screening test for anti-HIV-1 and anti-HIV-2 and at least one confirmatory test; Being on antiretroviral therapy for at least three months prior to the start of the study; Present current biochemical exams: Dyslipidemia, characterized by Total Cholesterol> 170mg / dL associated with: Triglycerides greater than or equal to LDL cholesterol ≥ 130 mg / dL; Availability to participate in the nutritional intervention with a low fat diet. Exclusion Criteria: Pregnant women; Patients with active opportunistic infections; Cognitive deficits; Diabetes mellitus; Patients taking lipid-lowering drugs; Patients who are unaware of their HIV diagnosis.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michelli S de Assis, PhD
    Organizational Affiliation
    Nurse Research
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Nutritional Therapy Improves Dyslipidemia in HIV Infected Teenagers With Antiretroviral Treatment

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