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

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ClinicalTrials.gov Identifier: NCT03421314
Recruitment Status : 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

Tracking Information
First Submitted Date  ICMJE January 10, 2018
First Posted Date  ICMJE February 5, 2018
Last Update Posted Date January 30, 2019
Actual Study Start Date  ICMJE September 1, 2016
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03421314 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2018)
  • Counts of CD4+ T cells [ Time Frame: Baseline,12 and 24 weeks ]
  • Changes in fasting serum glucose [ Time Frame: Baseline,12 and 24 weeks ]
  • Changes in blood pressure [ Time Frame: Baseline,12 and 24 weeks ]
  • Changes in lipid peroxidation [ Time Frame: Baseline and 24 weeks ]
    Measure by TBARS
  • Changes in proinflammatory cytokine profile [ Time Frame: Baseline and 24 weeks ]
    Measure by LUMINEX
  • Changes in bone metabolism biomarkers [ Time Frame: Baseline and 24 weeks ]
    Changes in osteoprotegerin and RANKL levels
  • Frequency of CD4+ T cells [ Time Frame: Baseline,12 and 24 weeks ]
    Measure by flow cytometry
  • Changes in total cholesterol [ Time Frame: Baseline,12 and 24 weeks ]
    in mg/dL
  • Changes in LDL cholesterol [ Time Frame: Baseline,12 and 24 weeks ]
    in mg/dL
  • Changes in HDL cholesterol [ Time Frame: Baseline,12 and 24 weeks ]
    in mg/dL
  • Changes in triglycerides [ Time Frame: Baseline,12 and 24 weeks ]
    in mg/dL
  • Changes in body weight [ Time Frame: Baseline,12 and 24 weeks ]
    in Kg
  • Changes in fat mass [ Time Frame: Baseline,12 and 24 weeks ]
    in Kg
  • Changes in lean soft tissue [ Time Frame: Baseline,12 and 24 weeks ]
    in Kg
  • Changes in and bone mineral density [ Time Frame: Baseline,12 and 24 weeks ]
    g/cm3
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Zinc and Selenium Supplementation on HIV+ Individuals on Antiretroviral Treatment.
Official Title  ICMJE Effect of Zinc and Selenium Supplementation on Clinical and Immunological Parameters on HIV+ Individuals on Antiretroviral Treatment.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
Triple
Primary Purpose: Supportive Care
Condition  ICMJE
  • HIV
  • ART
  • Zinc Deficiency
  • Selenium Deficiency
  • Metabolic Complication
  • Inflammation
Intervention  ICMJE Dietary Supplement: Zinc gluconate and/or Selenium yeast
30 mg dose of zinc gluconate and/or 200 mcg of selenium yeast
Study Arms  ICMJE
  • Experimental: Zinc
    Participants in this arm will take a daily 30 mg dose of zinc gluconate during 6 months
    Intervention: Dietary Supplement: Zinc gluconate and/or Selenium yeast
  • Experimental: Selenium
    Participants in this arm will take a daily 200 mcg of selenium yeast during 6 months
    Intervention: Dietary Supplement: Zinc gluconate and/or 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
    Intervention: Dietary Supplement: Zinc gluconate and/or Selenium yeast
  • No Intervention: Control
    Participants in this arm will not take supplementation as a control.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 29, 2018)
37
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03421314
Other Study ID Numbers  ICMJE C21-16
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gustavo Reyes-Teran, Instituto Nacional de Enfermedades Respiratorias
Study Sponsor  ICMJE Instituto Nacional de Enfermedades Respiratorias
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gustavo Reyes Teran, MD Principal investgator
PRS Account Instituto Nacional de Enfermedades Respiratorias
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP