NCT03421314

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
37

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

January 30, 2019

Status Verified

January 1, 2019

Enrollment Period

3.3 years

First QC Date

January 10, 2018

Last Update Submit

January 29, 2019

Conditions

HIVARTZinc DeficiencySelenium DeficiencyMetabolic ComplicationInflammation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (15)

  • 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

    Baseline and 24 weeks

  • Changes in proinflammatory cytokine profile

    Baseline and 24 weeks

  • +10 more secondary outcomes

Study Arms (4)

Zinc

EXPERIMENTAL

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

Selenium

EXPERIMENTAL

Participants in this arm will take a daily 200 mcg of selenium yeast during 6 months

Dietary Supplement: Zinc gluconate and/or Selenium yeast

Zinc + Selenium

EXPERIMENTAL

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

Control

NO INTERVENTION

Participants in this arm will not take supplementation as a control.

Interventions

Zinc gluconate and/or Selenium yeastDIETARY_SUPPLEMENT

30 mg dose of zinc gluconate and/or 200 mcg of selenium yeast

SeleniumZincZinc + Selenium

Eligibility Criteria

Age18 Years - 65 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV infected
  • \>200 CD4+ cells/mL
  • \>2 years under antiretroviral treatment
  • \>2 years under virology control (HIV RNA \<40 copies/mL)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro de Investigaciones en Enfermedades Infecciosas

Mexico City, Mexico City, 14080, Mexico

RECRUITING

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gustavo Reyes Teran, MD

    Principal investgator

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivan Osuna Padilla, MD

CONTACT

56667985ivan.osuna@cieni.org.mx

Olivia Briceño Cárdenas, PhD

CONTACT

56667985olivia@cieni.org.mx

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Triple
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 10, 2018

First Posted

February 5, 2018

Study Start

September 1, 2016

Primary Completion

December 31, 2019

Study Completion

January 1, 2020

Last Updated

January 30, 2019

Record last verified: 2019-01

Locations

ME(1)