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

Sponsor

Instituto Nacional de Enfermedades Respiratorias (Other)

Overall Status

Unknown status

CT.gov ID

NCT03421314

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Anticipated 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 :

Sep 1, 2016

Anticipated Primary Completion Date :

Dec 31, 2019

Anticipated Study Completion Date :

Jan 1, 2020

Arms and Interventions

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

Primary Outcome Measures

Changes from baseline in zinc and selenium plasmatic levels [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

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]
Measure by TBARS
Changes in proinflammatory cytokine profile [Baseline and 24 weeks]
Measure by LUMINEX
Changes in bone metabolism biomarkers [Baseline and 24 weeks]
Changes in osteoprotegerin and RANKL levels
Frequency of CD4+ T cells [Baseline,12 and 24 weeks]
Measure by flow cytometry
Changes in total cholesterol [Baseline,12 and 24 weeks]
in mg/dL
Changes in LDL cholesterol [Baseline,12 and 24 weeks]
in mg/dL
Changes in HDL cholesterol [Baseline,12 and 24 weeks]
in mg/dL
Changes in triglycerides [Baseline,12 and 24 weeks]
in mg/dL
Changes in body weight [Baseline,12 and 24 weeks]
in Kg
Changes in fat mass [Baseline,12 and 24 weeks]
in Kg
Changes in lean soft tissue [Baseline,12 and 24 weeks]
in Kg
Changes in and bone mineral density [Baseline,12 and 24 weeks]
g/cm3

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Centro de Investigaciones en Enfermedades Infecciosas	Mexico city	DF	Mexico	14080

Sponsors and Collaborators

Instituto Nacional de Enfermedades Respiratorias

Investigators

Principal Investigator: Gustavo Reyes Teran, MD, Principal investgator

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gustavo Reyes-Teran, Principal Investigator, Instituto Nacional de Enfermedades Respiratorias

ClinicalTrials.gov Identifier:

NCT03421314

Other Study ID Numbers:

C21-16

First Posted:

Feb 5, 2018

Last Update Posted:

Jan 30, 2019

Last Verified:

Jan 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Inflammation

Selenium

Study Results

No Results Posted as of Jan 30, 2019