Clinical trial NCT03021889: Nutritional Therapy Improves Dyslipidemia in HIV Infected Teenagers With Antiretroviral Treatment
Official title: Nutritional Therapy Improves Dyslipidemia in HIV Infected Teenagers With Antiretroviral Treatment: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Behavior
Hiv
Dyslipidemias
Keywords: HIV / AIDS
Dyslipidemia
Adolescents
Nutritional Therapy
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Centro Universitario La Salle
First posted: 2017-01-16
Enrollment: 20
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: Blood plasma level of total cholesterol
timeFrame: 12 months
Secondary outcomes:
measure: Food intake
timeFrame: 12 months
measure: Nutritional status
timeFrame: 12 months
measure: Blood plasma level of triglycerides
timeFrame: 12 months
measure: Blood plasma level of HDL cholesterol
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Nurse Research
name: Michelli S de Assis, PhD
role: PRINCIPAL_INVESTIGATOR
References: