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.

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.

Study Overview

• Status: Unknown
• Conditions: Inflammation; HIV; Zinc Deficiency; ART; Metabolic Complication; Selenium Deficiency
• Intervention / Treatment: Dietary supplement: Zinc gluconate and/or Selenium yeast

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 Type: Interventional
• Enrollment (Anticipated): 37
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ivan Osuna Padilla, MD; Phone Number: 109 56667985; Email: ivan.osuna@cieni.org.mx
• Study Contact Backup: Name: Olivia Briceño Cárdenas, PhD; Phone Number: 140 56667985; Email: olivia@cieni.org.mx

Study Locations

• Mexico
  • DF
    • Mexico city, DF, Mexico, 14080
      • Recruiting
      • Centro de Investigaciones en Enfermedades Infecciosas
      • Contact: Ivan Osuna Padilla, MD; Phone Number: 109 56667085; Email: ivan.osuna@cieni.org.mx
      • Principal Investigator: Gustavo Reyes-Terán, MD
      • Sub-Investigator: Ivan Osuna Padilla, MD
      • Sub-Investigator: Olivia Briceño Cárdenas, PhD
      • Sub-Investigator: Nadia Rodriguez Moguel, MD
      • Sub-Investigator: Adriana Aguilar Vargas, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Zinc; Participants in this arm will take a daily 30 mg dose of zinc gluconate during 6 months	Dietary supplement: Zinc gluconate and/or Selenium yeast; 30 mg dose of zinc gluconate and/or 200 mcg of selenium yeast
Experimental: Selenium; Participants in this arm will take a daily 200 mcg of selenium yeast during 6 months	Dietary supplement: Zinc gluconate and/or Selenium yeast; 30 mg dose of zinc gluconate and/or 200 mcg of selenium yeast
Experimental: Zinc + Selenium; Participants in this arm will take a daily 30 mg dose of zinc gluconate + 200 mcg of selenium yeast during 6 months	Dietary supplement: Zinc gluconate and/or Selenium yeast; 30 mg dose of zinc gluconate and/or 200 mcg of selenium yeast
No Intervention: Control; Participants in this arm will not take supplementation as a control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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		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

Collaborators and Investigators

• Sponsor: Instituto Nacional de Enfermedades Respiratorias
• Investigators: Principal Investigator: Gustavo Reyes Teran, MD, Principal investgator

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: January 10, 2018
• First Submitted That Met QC Criteria: January 29, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): January 30, 2019
• Last Update Submitted That Met QC Criteria: January 29, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Trace Elements; Micronutrients; Antioxidants; Selenium
• Other Study ID Numbers: C21-16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No