Omega-3 Supplementation in HIV Patients With Therapeutic Lifestyle Change Diet.
Condition: Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      The positive patients to the Human Immunodeficiency Virus (HIV) with Highly Active
      Antiretroviral Therapy (HAART) present multiple alterations in their corporal composition and
      dyslipidemia, wich increase the cardiovascular risk.

      The investigators evaluated the efficiency of the combination of fish oil omega 3 fatty acids
      to different doses with the Therapeutic Lifestyle Changes (TLC) diet of the National
      Cholesterol Education Program on the profile of lipids and the corporal weight in patients
      with HIV treated with HAART.
    

Detailed description: 
      The infection by Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome
      (AIDS), is a chronic condition transmissible and progressive type of viral cause, in which a
      link is very different between host and virus, which ultimately influences the appearance of
      opportunistic morbid processes or rare tumors, or both1.

      With a prevalence of 3 cases for every 1000 people from 15 to 49 years, Mexico ranks 16th
      place in the prevalence of HIV/AIDS in adults in Latin America2.

      The state of Jalisco, México, occupies the fourth place in terms of positive cases of
      HIV-AIDS, in this same plane, the municipalities of Guadalajara, Zapopan, Tlaquepaque and
      Puerto Vallarta in Jalisco, represent the main populations with the highest number of
      positive cases by HIV-AIDS.

      The HIV positive individuals with Highly Active Antiretroviral Therapy (HAART) or without
      treatment are facing numerous challenges in terms of management of their health; some of the
      most disturbing changes are visible in the shape and appearance of the body. In most cases
      this anatomical changes come accompanied by alterations in biochemical indicators: lipid
      levels (cholesterol and triglycerides) and insulin resistance4.These adverse effects may have
      important clinical implications, such as severe lactic acidosis, coronary artery disease and
      acute pancreatitis5.

      In patients with HIV and HAART has published an incidence of hypercholesterolemia and
      hypertriglyceridemia between 5 and 90% depending on the series, although the true incidence
      is yet to be determined6. Pharmacological interventions with statins or fibrates in patients
      infected with HIV are limited partially due to the drug interactions and increase in the
      frequency of adverse effects7.

      Therefore, it is necessary to investigate new alternatives for the management of dyslipidemia
      in patients infected with HIV with HAART through changes in diet and supplements of fish oil
      omega 3 fatty acids.

      Methods Patients: The investigators enrolled 100 Patients positive to Human Immunodeficiency
      Virus or Acquired Immunodeficiency Syndrome, and had been receiving ≥2 Highly Active
      Antiretroviral Therapy, and with diagnostic of dislipidemia according the Mexican Official
      Standard Norms of 2002, for the prevention, treatment and control of dyslipidemias8.

      All the patients were active in the SMART database from HIV/AIDS department of the Civil
      Hospital in Guadalajara "Fray Antonio Alcalde". Patients were excluded for intolerance or
      allergy to fish, patients that use or have used in the last 6 weeks supplements or drugs that
      modify lipids.

      Study design During the period from January 2010 to July 2011, was carried out the study with
      the authorization of the ethics committee of the Civil Hospital in Guadalajara "Fray Antonio
      Alcalde".

      Our subjects were assigned to 5 intervention groups: Groups one= 20 subjects received
      Therapeutic Lifestyle Changes diet more 1.05 grams of Fatty Acid omega 3. Groups two= 20
      subjects received conventional diet more 1.05 grams of Fatty Acid omega three. Groups 3=20
      subjects received Therapeutic Lifestyle Changes diet more 2.10 grams of Fatty Acid omega 3.
      Groups four=20 subjects received conventional diet more 2.10 grams of Fatty Acid omega 3.
      Groups five= 20 subjects, control group received conventional diet.

      The subject assigned to group one and three with TLC diet, received advice from the
      nutritionist in week 4 and 12 to encourage the consumption of the capsules of omega 3 fatty
      acids, in addition offered general recommendations to consume dietary fiber and fluids.

      The subject assigned to groups two and four with conventional diet, received advice from the
      nutritionist in the week 4 and 12 to encourage the consumption of the capsules of omega 3
      fatty acids without the assistance of special diet.

      The requirements of energy and macronutrients were identified in the patients of group one
      and three.

      None of the subjects received advice on the physical activity that could perform.

      Statistical analysis

      The main objective of this study was to compare the changes in fasting levels of
      triglycerides (TG), total cholesterol (TC), high density cholesterol (HD-C), low density
      cholesterol (LD-C), very low density cholesterol (VLD-C), the body weight and body mass index
      (BMI) against the week 4 and 12.

      The safety and tolerability of the study medication were also secondary outcomes.

      Statistical analysis was carried out starting with the Kolmogorov-Smirnov test to identify
      the distribution of variables, then identify the type of distribution of each variable, is
      continuous with the descriptive statistical analysis for variables with abnormal distribution
      -non-parametric, with measures of central tendency and dispersion as: the median distance and
      interquartiles and variables with normal distribution - parametric- :the mean and standard
      deviation.

      Inferential analysis to the intra-group used the Wilcoxon test and Friedman. For the
      inferential analysis between groups was implemented in the variables of non-normal
      distribution, the Kruskal-Wallis test; and for variables with normal distribution was used
      the one-way ANOVA test. Differences were considered statistically significant when the p
      value was <0.05 .

      The data were processed using the statistical package No.18.0 and are presented in tables and
      graphics.
    

Intervention name(s): Omega-3 fatty acids; TLC nutritional intervention; Omega-3 fatty acid supplementation with fish oil and TLC nutritional intervention.
Intervention type(s): Dietary Supplement; Behavioral; Dietary Supplement
Intervention description(s): Omega-3 fatty acid supplementation with fish oil.; nutritional orientation.; Omega 3 fatty acid supplementation with fish oil and nutritional counseling of TLC diet.
Other intervention name(s): eicosapentaenoic acid; docosahexaenoic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Omega-3 Fatty Acids; Therapeutic Lifestyle Changes; Human Immunodeficiency Virus; Cardiac Risk; Dyslipidemia