Nutritional Therapy Improves Dyslipidemia in HIV Infected Teenagers With Antiretroviral Treatment

Not Applicable

Completed

• Conditions: Adolescent Behavior; Hiv; Dyslipidemias
• Interventions: Behavioral: Control group; Behavioral: Nutritional therapy

• Registration Number: NCT03021889
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-05
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Study First Submitted: 2017-01-11
• Study First Submitted QC: 2017-01-12
• Study First Posted: 2017-01-16
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-22
• Last Update Posted: 2017-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Blood plasma level of total cholesterol	12 months	Total blood cholesterol level will be assessed by blood test

Secondary Outcome Measures

Name	Time	Method
Blood plasma level of triglycerides	12 months	Triglycerides level will be assessed by blood test
Food intake	12 months	Food intake will be assessed a 24-hour reminder
Nutritional status	12 months	Will be assessed by body mass index
Blood plasma level of HDL cholesterol	12 months	HDL cholesterol level will be assessed by blood test