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

Not Applicable

• Conditions: Metabolic Complication; Inflammation; HIV; Zinc Deficiency; ART; Selenium Deficiency
• Interventions: Dietary Supplement: Zinc gluconate and/or Selenium yeast

• Registration Number: NCT03421314
• Lead Sponsor: Instituto Nacional de Enfermedades Respiratorias

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.

Study Timeline

• Study Start: 2016-09-01
• Study First Submitted: 2018-01-10
• Study First Submitted QC: 2018-01-29
• Study First Posted: 2018-02-05
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-30
• Primary Completion: 2019-12-31
• Study Completion: 2020-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 37

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zinc	Zinc gluconate and/or Selenium yeast	Participants in this arm will take a daily 30 mg dose of zinc gluconate during 6 months
Selenium	Zinc gluconate and/or Selenium yeast	Participants in this arm will take a daily 200 mcg of selenium yeast during 6 months
Zinc + Selenium	Zinc gluconate and/or Selenium yeast	Participants in this arm will take a daily 30 mg dose of zinc gluconate + 200 mcg of selenium yeast during 6 months

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Changes in lean soft tissue	Baseline,12 and 24 weeks	in Kg
Counts of CD4+ T cells	Baseline,12 and 24 weeks
Changes in LDL cholesterol	Baseline,12 and 24 weeks	in mg/dL
Changes in triglycerides	Baseline,12 and 24 weeks	in mg/dL
Frequency of CD4+ T cells	Baseline,12 and 24 weeks	Measure by flow cytometry
Changes in HDL cholesterol	Baseline,12 and 24 weeks	in mg/dL
Changes in fat mass	Baseline,12 and 24 weeks	in Kg
Changes in fasting serum glucose	Baseline,12 and 24 weeks
Changes in and bone mineral density	Baseline,12 and 24 weeks	g/cm3
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 total cholesterol	Baseline,12 and 24 weeks	in mg/dL
Changes in body weight	Baseline,12 and 24 weeks	in Kg
Changes in blood pressure	Baseline,12 and 24 weeks
Changes in bone metabolism biomarkers	Baseline and 24 weeks	Changes in osteoprotegerin and RANKL levels

Trial Locations

Locations (1)

Centro de Investigaciones en Enfermedades Infecciosas; 🇲🇽 Mexico city, DF, Mexico