ART, HIV, Inflammation, Metabolic Complication, Selenium Deficiency, Zinc Deficiency
Conditions
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTZinc gluconate and/or Selenium yeast
30 mg dose of zinc gluconate and/or 200 mcg of selenium yeast
Sponsors
Instituto Nacional de Enfermedades Respiratorias
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Triple
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in zinc and selenium plasmatic levels | Baseline and 24 weeks | We evaluated the effects of zinc (30mg/d) and selenium (200μg/d) supplementation on plasma zinc and selenium levels. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline and 24 weeks | Measure by TBARS |
| Changes in proinflammatory cytokine profile | Baseline and 24 weeks | Measure by LUMINEX |
| Changes in bone metabolism biomarkers | Baseline and 24 weeks | Changes in osteoprotegerin and RANKL levels |
| Frequency of CD4+ T cells | Baseline,12 and 24 weeks | Measure by flow cytometry |
| Changes in total cholesterol | Baseline,12 and 24 weeks | in mg/dL |
| Changes in LDL cholesterol | Baseline,12 and 24 weeks | in mg/dL |
| Changes in HDL cholesterol | Baseline,12 and 24 weeks | in mg/dL |
| Changes in triglycerides | Baseline,12 and 24 weeks | in mg/dL |
| Changes in body weight | Baseline,12 and 24 weeks | in Kg |
| Changes in fat mass | Baseline,12 and 24 weeks | in Kg |
| Changes in lean soft tissue | Baseline,12 and 24 weeks | in Kg |
| Changes in and bone mineral density | Baseline,12 and 24 weeks | g/cm3 |
Countries
Mexico
Contacts
Primary ContactIvan Osuna Padilla, MD
Backup ContactOlivia Briceño Cárdenas, PhD
Outcome results
None listed