ClinicalTrials.gov
ClinicalTrials.gov Menu

Nutritional Therapy Improves Dyslipidemia in HIV Infected Teenagers With Antiretroviral Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03021889
Recruitment Status : Completed
First Posted : January 16, 2017
Last Update Posted : August 23, 2017
Sponsor:
Collaborator:
Centro Universitario La Salle
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

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.


Condition or disease Intervention/treatment Phase
Adolescent Behavior Hiv Dyslipidemias Behavioral: Nutritional therapy Behavioral: Control group Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Supportive Care
Official Title: Nutritional Therapy Improves Dyslipidemia in HIV Infected Teenagers With Antiretroviral Treatment: a Randomized Controlled Trial
Actual Study Start Date : May 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nutritional therapy group
The group nutritional therapy intervention was subjected to a protocol that included: nutritional counseling and weekly phone calls for 12 weeks.
Behavioral: Nutritional therapy
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.

Control group
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.
Behavioral: Control group
The control group was followed according to the ambulatory care routine, which consists of medical follow-up by the assistant team.




Primary Outcome Measures :
  1. Blood plasma level of total cholesterol [ Time Frame: 12 months ]
    Total blood cholesterol level will be assessed by blood test


Secondary Outcome Measures :
  1. Food intake [ Time Frame: 12 months ]
    Food intake will be assessed a 24-hour reminder

  2. Nutritional status [ Time Frame: 12 months ]
    Will be assessed by body mass index

  3. Blood plasma level of triglycerides [ Time Frame: 12 months ]
    Triglycerides level will be assessed by blood test

  4. Blood plasma level of HDL cholesterol [ Time Frame: 12 months ]
    HDL cholesterol level will be assessed by blood test



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03021889


Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Centro Universitario La Salle
Investigators
Principal Investigator: Michelli S de Assis, PhD Nurse Research

Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT03021889     History of Changes
Other Study ID Numbers: 150018
First Posted: January 16, 2017    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Hospital de Clinicas de Porto Alegre:
HIV / AIDS
Dyslipidemia
Adolescents
Nutritional Therapy

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases