NCT03021889

Nutritional Therapy Improves Dyslipidemia in HIV Infected Teenagers With Antiretroviral Treatment

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Hospital de Clinicas de Porto Alegre · Academic / Other
• Sex: All
• Age: 13 Years – 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adolescent Behavior
• Hiv
• Dyslipidemias

Interventions

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

Timeline

• Start date: 2015-05-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2017-01-16
• Last updated: 2017-08-23