The aim of this study is to evaluate the effect of zinc gluconate and/or selenium yeast supplementation during six months on clinical (glucose, cholesterol, triglycerides, bone mineral density and body composition) and immunological (oxidative stress, CD4+ count and pro-inflammatory cytokines) parameters in a population with HIV diagnosis on antiretroviral treatment.
HIV-infected individuals on antiretroviral treatment have lowest risk of AIDS events and more life expectancy. However, antiretroviral treatment does not fully restore the immune system in all individuals due to persistent immune activation and inflammation, increasing the risk of non-AIDS complications, such as insulin resistance, diabetes, hypertension, dyslipidemia, obesity, low bone mass density, oxidative stress and micronutrient deficiencies. Several studies showed that HIV+ patients present zinc and selenium deficiency. Those micronutrients are involved in the pathogenesis of metabolic complications and have a major role in maintaining immune system function. It remains unknown the effect of zinc and selenium supplementation on metabolic and immunological parameters associated to non-AIDS complications.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
37
30 mg dose of zinc gluconate and/or 200 mcg of selenium yeast
Centro de Investigaciones en Enfermedades Infecciosas
Mexico City, Mexico City, Mexico
RECRUITINGChanges from baseline in zinc and selenium plasmatic levels
We evaluated the effects of zinc (30mg/d) and selenium (200μg/d) supplementation on plasma zinc and selenium levels.
Time frame: Baseline and 24 weeks
Counts of CD4+ T cells
Time frame: Baseline,12 and 24 weeks
Changes in fasting serum glucose
Time frame: Baseline,12 and 24 weeks
Changes in blood pressure
Time frame: Baseline,12 and 24 weeks
Changes in lipid peroxidation
Measure by TBARS
Time frame: Baseline and 24 weeks
Changes in proinflammatory cytokine profile
Measure by LUMINEX
Time frame: Baseline and 24 weeks
Changes in bone metabolism biomarkers
Changes in osteoprotegerin and RANKL levels
Time frame: Baseline and 24 weeks
Frequency of CD4+ T cells
Measure by flow cytometry
Time frame: Baseline,12 and 24 weeks
Changes in total cholesterol
in mg/dL
Time frame: Baseline,12 and 24 weeks
Changes in LDL cholesterol
in mg/dL
Time frame: Baseline,12 and 24 weeks
Changes in HDL cholesterol
in mg/dL
Time frame: Baseline,12 and 24 weeks
Changes in triglycerides
in mg/dL
Time frame: Baseline,12 and 24 weeks
Changes in body weight
in Kg
Time frame: Baseline,12 and 24 weeks
Changes in fat mass
in Kg
Time frame: Baseline,12 and 24 weeks
Changes in lean soft tissue
in Kg
Time frame: Baseline,12 and 24 weeks
Changes in and bone mineral density
g/cm3
Time frame: Baseline,12 and 24 weeks
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