NCT03021889

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 16, 2017

Completed
Last Updated

August 23, 2017

Status Verified

August 1, 2017

Enrollment Period

6 months

First QC Date

January 11, 2017

Last Update Submit

August 22, 2017

Conditions

Adolescent BehaviorHivDyslipidemias

Keywords

HIV / AIDSDyslipidemiaAdolescentsNutritional Therapy

Outcome Measures

Primary Outcomes (1)

  • Blood plasma level of total cholesterol

    Total blood cholesterol level will be assessed by blood test

    12 months

Secondary Outcomes (4)

  • Food intake

    12 months

  • Nutritional status

    12 months

  • Blood plasma level of triglycerides

    12 months

  • Blood plasma level of HDL cholesterol

    12 months

Study Arms (2)

Nutritional therapy group

EXPERIMENTAL

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

Behavioral: Nutritional therapy

Control group

OTHER

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

Interventions

Nutritional therapyBEHAVIORAL

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.

Nutritional therapy group
Control groupBEHAVIORAL

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

Control group

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Adolescent BehaviorAcquired Immunodeficiency SyndromeDyslipidemias

Interventions

Nutrition TherapyControl Groups

Condition Hierarchy (Ancestors)

BehaviorHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Michelli S de Assis, PhD

    Nurse Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2017

First Posted

January 16, 2017

Study Start

May 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

August 23, 2017

Record last verified: 2017-08