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

National Institute of Respiratory Diseases (INER)

Status: Unknown

Conditions: Inflammation; Selenium Deficiency; HIV; Metabolic Complication; Zinc Deficiency; ART

Treatments: Dietary Supplement: Zinc gluconate and/or Selenium yeast

Study type: Interventional

Funder types: Other

Identifiers

NCT03421314

C21-16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 estimated patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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37 participants in 4 patient groups

Zinc

Experimental group

Description:

Participants in this arm will take a daily 30 mg dose of zinc gluconate during 6 months

Treatment:

Dietary Supplement: Zinc gluconate and/or Selenium yeast

Selenium

Experimental group

Description:

Participants in this arm will take a daily 200 mcg of selenium yeast during 6 months

Treatment:

Dietary Supplement: Zinc gluconate and/or Selenium yeast

Zinc + Selenium

Experimental group

Description:

Participants in this arm will take a daily 30 mg dose of zinc gluconate + 200 mcg of selenium yeast during 6 months

Treatment:

Dietary Supplement: Zinc gluconate and/or Selenium yeast

Control

No Intervention group

Description:

Participants in this arm will not take supplementation as a control.