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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-01

Study Completion Date

2020-01-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV ART Zinc Deficiency Selenium Deficiency Metabolic Complication Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Triple

Study Groups

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Zinc

Participants in this arm will take a daily 30 mg dose of zinc gluconate during 6 months

Group Type EXPERIMENTAL

Zinc gluconate and/or Selenium yeast

Intervention Type DIETARY_SUPPLEMENT

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

Selenium

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

Group Type EXPERIMENTAL

Zinc gluconate and/or Selenium yeast

Intervention Type DIETARY_SUPPLEMENT

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

Zinc + Selenium

Participants in this arm will take a daily 30 mg dose of zinc gluconate + 200 mcg of selenium yeast during 6 months

Group Type EXPERIMENTAL

Zinc gluconate and/or Selenium yeast

Intervention Type DIETARY_SUPPLEMENT

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

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Zinc gluconate and/or Selenium yeast

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No