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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zinc | Experimental | Participants in this arm will take a daily 30 mg dose of zinc gluconate during 6 months |
|
| Selenium | Experimental | Participants in this arm will take a daily 200 mcg of selenium yeast during 6 months |
|
| Zinc + Selenium | Experimental | Participants in this arm will take a daily 30 mg dose of zinc gluconate + 200 mcg of selenium yeast during 6 months |
|
| Control | No Intervention | Participants in this arm will not take supplementation as a control. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zinc gluconate and/or Selenium yeast | Dietary Supplement | 30 mg dose of zinc gluconate and/or 200 mcg of selenium yeast |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ivan Osuna Padilla, MD | Contact | 56667985 | 109 | ivan.osuna@cieni.org.mx |
| Olivia Briceño Cárdenas, PhD | Contact | 56667985 | 140 | olivia@cieni.org.mx |
| Name | Affiliation | Role |
|---|---|---|
| Gustavo Reyes Teran, MD | Principal investgator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Investigaciones en Enfermedades Infecciosas | Recruiting | Mexico City | Mexico City | 14080 | Mexico |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Triple
| 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 |