Effect of Zinc and Selenium Supplementation on HIV+ Individuals on Antiretroviral Treatment.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Zinc and Selenium Supplementation on Clinical and Immunological Parameters on HIV+ Individuals on Antiretroviral Treatment.

Conditions
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ART, HIV, Zinc Deficiency, Selenium Deficiency, Metabolic Complication, Inflammation

Intervention / Treatment
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* Dietary Supplement: Zinc gluconate and/or Selenium yeast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV infected >200 CD4+ cells/mL >2 years under antiretroviral treatment >2 years under virology control (HIV RNA <40 copies/mL) Exclusion Criteria: Patients with opportunistic infection Patients taking vitamin-mineral supplements Patients with moderate or high cardiovascular risk (Framingham score higher than 10%) and cholesterol LDL >190 mg/dL or triglycerides >500 mg/dL. Patients with diabetes or hypertension diagnosis. Patients taking drugs for diabetes, hypertension, dyslipidemia or low bone mass density. Low adherence to supplementation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zinc<br>Participants in this arm will take a daily 30 mg dose of zinc gluconate during 6 months | Dietary Supplement: Zinc gluconate and/or Selenium yeast<br>* 30 mg dose of zinc gluconate and/or 200 mcg of selenium yeast<br>|
| Experimental: Selenium<br>Participants in this arm will take a daily 200 mcg of selenium yeast during 6 months | Dietary Supplement: Zinc gluconate and/or Selenium yeast<br>* 30 mg dose of zinc gluconate and/or 200 mcg of selenium yeast<br>|
| Experimental: Zinc + Selenium<br>Participants in this arm will take a daily 30 mg dose of zinc gluconate + 200 mcg of selenium yeast during 6 months | Dietary Supplement: Zinc gluconate and/or Selenium yeast<br>* 30 mg dose of zinc gluconate and/or 200 mcg of selenium yeast<br>|
| No Intervention: Control<br>Participants in this arm will not take supplementation as a control. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes 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. | Baseline and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Counts of CD4+ T cells |  | Baseline,12 and 24 weeks | 
| Changes in fasting serum glucose |  | Baseline,12 and 24 weeks | 
| Changes in blood pressure |  | Baseline,12 and 24 weeks | 
| Changes in lipid peroxidation | Measure by TBARS | Baseline and 24 weeks | 
| Changes in proinflammatory cytokine profile | Measure by LUMINEX | Baseline and 24 weeks | 
| Changes in bone metabolism biomarkers | Changes in osteoprotegerin and RANKL levels | Baseline and 24 weeks | 
| Frequency of CD4+ T cells | Measure by flow cytometry | Baseline,12 and 24 weeks | 
| Changes in total cholesterol | in mg/dL | Baseline,12 and 24 weeks | 
| Changes in LDL cholesterol | in mg/dL | Baseline,12 and 24 weeks | 
| Changes in HDL cholesterol | in mg/dL | Baseline,12 and 24 weeks | 
| Changes in triglycerides | in mg/dL | Baseline,12 and 24 weeks | 
| Changes in body weight | in Kg | Baseline,12 and 24 weeks | 
| Changes in fat mass | in Kg | Baseline,12 and 24 weeks | 
| Changes in lean soft tissue | in Kg | Baseline,12 and 24 weeks | 
| Changes in and bone mineral density | g/cm3 | Baseline,12 and 24 weeks |