Nutritional Therapy Improves Dyslipidemia in HIV Infected Teenagers With Antiretroviral Treatment
Primary Purpose
Adolescent Behavior, Hiv, Dyslipidemias
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nutritional therapy
Control group
Sponsored by
About this trial
This is an interventional supportive care trial for Adolescent Behavior focused on measuring HIV / AIDS, Dyslipidemia, Adolescents, Nutritional Therapy
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Nutritional therapy group
Control group
Arm Description
The group nutritional therapy intervention was subjected to a protocol that included: nutritional counseling and weekly phone calls for 12 weeks.
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.
Outcomes
Primary Outcome Measures
Blood plasma level of total cholesterol
Total blood cholesterol level will be assessed by blood test
Secondary Outcome Measures
Food intake
Food intake will be assessed a 24-hour reminder
Nutritional status
Will be assessed by body mass index
Blood plasma level of triglycerides
Triglycerides level will be assessed by blood test
Blood plasma level of HDL cholesterol
HDL cholesterol level will be assessed by blood test
Full Information
NCT ID
NCT03021889
First Posted
January 11, 2017
Last Updated
August 22, 2017
Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Centro Universitario La Salle
1. Study Identification
Unique Protocol Identification Number
NCT03021889
Brief Title
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
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Centro Universitario La Salle
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Behavior, Hiv, Dyslipidemias
Keywords
HIV / AIDS, Dyslipidemia, Adolescents, Nutritional Therapy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nutritional therapy group
Arm Type
Experimental
Arm Description
The group nutritional therapy intervention was subjected to a protocol that included: nutritional counseling and weekly phone calls for 12 weeks.
Arm Title
Control group
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nutritional therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control group
Intervention Description
The control group was followed according to the ambulatory care routine, which consists of medical follow-up by the assistant team.
Primary Outcome Measure Information:
Title
Blood plasma level of total cholesterol
Description
Total blood cholesterol level will be assessed by blood test
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Food intake
Description
Food intake will be assessed a 24-hour reminder
Time Frame
12 months
Title
Nutritional status
Description
Will be assessed by body mass index
Time Frame
12 months
Title
Blood plasma level of triglycerides
Description
Triglycerides level will be assessed by blood test
Time Frame
12 months
Title
Blood plasma level of HDL cholesterol
Description
HDL cholesterol level will be assessed by blood test
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelli S de Assis, PhD
Organizational Affiliation
Nurse Research
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Nutritional Therapy Improves Dyslipidemia in HIV Infected Teenagers With Antiretroviral Treatment
We'll reach out to this number within 24 hrs