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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03421314
Recruitment Status : Unknown
Verified January 2019 by Gustavo Reyes-Teran, Instituto Nacional de Enfermedades Respiratorias.
Recruitment status was:  Recruiting
First Posted : February 5, 2018
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Gustavo Reyes-Teran, Instituto Nacional de Enfermedades Respiratorias

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV ART Zinc Deficiency Selenium Deficiency Metabolic Complication Inflammation Dietary Supplement: Zinc gluconate and/or Selenium yeast Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Triple
Primary Purpose: Supportive Care
Official Title: Effect of Zinc and Selenium Supplementation on Clinical and Immunological Parameters on HIV+ Individuals on Antiretroviral Treatment.
Actual Study Start Date : September 1, 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Counts of CD4+ T cells [ Time Frame: Baseline,12 and 24 weeks ]
  2. Changes in fasting serum glucose [ Time Frame: Baseline,12 and 24 weeks ]
  3. Changes in blood pressure [ Time Frame: Baseline,12 and 24 weeks ]
  4. Changes in lipid peroxidation [ Time Frame: Baseline and 24 weeks ]
    Measure by TBARS

  5. Changes in proinflammatory cytokine profile [ Time Frame: Baseline and 24 weeks ]
    Measure by LUMINEX

  6. Changes in bone metabolism biomarkers [ Time Frame: Baseline and 24 weeks ]
    Changes in osteoprotegerin and RANKL levels

  7. Frequency of CD4+ T cells [ Time Frame: Baseline,12 and 24 weeks ]
    Measure by flow cytometry

  8. Changes in total cholesterol [ Time Frame: Baseline,12 and 24 weeks ]
    in mg/dL

  9. Changes in LDL cholesterol [ Time Frame: Baseline,12 and 24 weeks ]
    in mg/dL

  10. Changes in HDL cholesterol [ Time Frame: Baseline,12 and 24 weeks ]
    in mg/dL

  11. Changes in triglycerides [ Time Frame: Baseline,12 and 24 weeks ]
    in mg/dL

  12. Changes in body weight [ Time Frame: Baseline,12 and 24 weeks ]
    in Kg

  13. Changes in fat mass [ Time Frame: Baseline,12 and 24 weeks ]
    in Kg

  14. Changes in lean soft tissue [ Time Frame: Baseline,12 and 24 weeks ]
    in Kg

  15. Changes in and bone mineral density [ Time Frame: Baseline,12 and 24 weeks ]
    g/cm3


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03421314


Contacts
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Contact: Ivan Osuna Padilla, MD 56667985 ext 109 ivan.osuna@cieni.org.mx
Contact: Olivia Briceño Cárdenas, PhD 56667985 ext 140 olivia@cieni.org.mx

Locations
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Mexico
Centro de Investigaciones en Enfermedades Infecciosas Recruiting
Mexico city, DF, Mexico, 14080
Contact: Ivan Osuna Padilla, MD    56667085 ext 109    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         
Sponsors and Collaborators
Instituto Nacional de Enfermedades Respiratorias
Investigators
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Principal Investigator: Gustavo Reyes Teran, MD Principal investgator
More Information
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Responsible Party: Gustavo Reyes-Teran, Principal Investigator, Instituto Nacional de Enfermedades Respiratorias
ClinicalTrials.gov Identifier: NCT03421314    
Other Study ID Numbers: C21-16
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes
Selenium
Antioxidants
Molecular Mechanisms of Pharmacological Action
 Protective Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients