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

January 29, 2019 updated by: Gustavo Reyes-Teran, Instituto Nacional de Enfermedades Respiratorias

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
37

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Mexico
    • DF
      • Mexico city, DF, Mexico, 14080
        • Recruiting
        • Centro de Investigaciones en Enfermedades Infecciosas
        • Contact:
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes from baseline in zinc and selenium plasmatic levels
Time Frame: Baseline and 24 weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Counts of CD4+ T cells
Time Frame: Baseline,12 and 24 weeks
Baseline,12 and 24 weeks
Changes in fasting serum glucose
Time Frame: Baseline,12 and 24 weeks
Baseline,12 and 24 weeks
Changes in blood pressure
Time Frame: Baseline,12 and 24 weeks
Baseline,12 and 24 weeks
Changes in lipid peroxidation
Time Frame: Baseline and 24 weeks
Measure by TBARS
Baseline and 24 weeks
Changes in proinflammatory cytokine profile
Time Frame: Baseline and 24 weeks
Measure by LUMINEX
Baseline and 24 weeks
Changes in bone metabolism biomarkers
Time Frame: Baseline and 24 weeks
Changes in osteoprotegerin and RANKL levels
Baseline and 24 weeks
Frequency of CD4+ T cells
Time Frame: Baseline,12 and 24 weeks
Measure by flow cytometry
Baseline,12 and 24 weeks
Changes in total cholesterol
Time Frame: Baseline,12 and 24 weeks
in mg/dL
Baseline,12 and 24 weeks
Changes in LDL cholesterol
Time Frame: Baseline,12 and 24 weeks
in mg/dL
Baseline,12 and 24 weeks
Changes in HDL cholesterol
Time Frame: Baseline,12 and 24 weeks
in mg/dL
Baseline,12 and 24 weeks
Changes in triglycerides
Time Frame: Baseline,12 and 24 weeks
in mg/dL
Baseline,12 and 24 weeks
Changes in body weight
Time Frame: Baseline,12 and 24 weeks
in Kg
Baseline,12 and 24 weeks
Changes in fat mass
Time Frame: Baseline,12 and 24 weeks
in Kg
Baseline,12 and 24 weeks
Changes in lean soft tissue
Time Frame: Baseline,12 and 24 weeks
in Kg
Baseline,12 and 24 weeks
Changes in and bone mineral density
Time Frame: Baseline,12 and 24 weeks
g/cm3
Baseline,12 and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Instituto Nacional de Enfermedades Respiratorias

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gustavo Reyes Teran, MD, Principal investgator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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