Nutritional Therapy Improves Dyslipidemia in HIV Infected Teenagers With Antiretroviral Treatment

Hiv Clinical Trial

Official title:

Nutritional Therapy Improves Dyslipidemia in HIV Infected Teenagers With Antiretroviral Treatment: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03021889
• Other study ID #: 150018
• Status: Completed
• Phase: N/A
• First received: January 11, 2017
• Last updated: August 22, 2017
• Start date: May 2015
• Est. completion date: November 2015

Study information

• Verified date: August 2017
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 19 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adolescent Behavior
• Dyslipidemias
• Hiv

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Centro Universitario La Salle

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood plasma level of total cholesterol	Total blood cholesterol level will be assessed by blood test	12 months
Secondary	Food intake	Food intake will be assessed a 24-hour reminder	12 months
Secondary	Nutritional status	Will be assessed by body mass index	12 months
Secondary	Blood plasma level of triglycerides	Triglycerides level will be assessed by blood test	12 months
Secondary	Blood plasma level of HDL cholesterol	HDL cholesterol level will be assessed by blood test	12 months