NCT03421314

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: Instituto Nacional de Enfermedades Respiratorias · Other Government
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV
• ART
• Zinc Deficiency
• Selenium Deficiency
• Metabolic Complication
• Inflammation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Zinc gluconate and/or Selenium yeast	30 mg dose of zinc gluconate and/or 200 mcg of selenium yeast

Timeline

• Start date: 2016-09-01
• Primary completion: 2019-12-31
• Completion: 2020-01-01
• First posted: 2018-02-05
• Last updated: 2019-01-30

Locations

1 site across 1 country: Mexico