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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03021889
Enrollment
20
Registered
2017-01-16
Start date
2015-05-31
Completion date
2015-11-30
Last updated
2017-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Behavior, Hiv, Dyslipidemias

Keywords

HIV / AIDS, Dyslipidemia, Adolescents, Nutritional Therapy

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.

Interventions

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.

BEHAVIORALControl group

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

Sponsors

Centro Universitario La Salle
CollaboratorOTHER
Hospital de Clinicas de Porto Alegre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
13 Years to 19 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Blood plasma level of total cholesterol12 monthsTotal blood cholesterol level will be assessed by blood test

Secondary

MeasureTime frameDescription
Food intake12 monthsFood intake will be assessed a 24-hour reminder
Nutritional status12 monthsWill be assessed by body mass index
Blood plasma level of triglycerides12 monthsTriglycerides level will be assessed by blood test
Blood plasma level of HDL cholesterol12 monthsHDL cholesterol level will be assessed by blood test

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026