Clinical trial NCT03421314: Effect of Zinc and Selenium Supplementation on HIV+ Individuals on Antiretroviral Treatment.
Official title: Effect of Zinc and Selenium Supplementation on Clinical and Immunological Parameters on HIV+ Individuals on Antiretroviral Treatment.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV
ART
Zinc Deficiency
Selenium Deficiency
Metabolic Complication
Inflammation
Lead sponsor: Instituto Nacional de Enfermedades Respiratorias
Sponsor class: OTHER_GOV
First posted: 2018-02-05
Enrollment: 37
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: Changes from baseline in zinc and selenium plasmatic levels
timeFrame: Baseline and 24 weeks
Secondary outcomes:
measure: Counts of CD4+ T cells
timeFrame: Baseline,12 and 24 weeks
measure: Changes in fasting serum glucose
timeFrame: Baseline,12 and 24 weeks
measure: Changes in blood pressure
timeFrame: Baseline,12 and 24 weeks
measure: Changes in lipid peroxidation
timeFrame: Baseline and 24 weeks
measure: Changes in proinflammatory cytokine profile
timeFrame: Baseline and 24 weeks
measure: Changes in bone metabolism biomarkers
timeFrame: Baseline and 24 weeks
measure: Frequency of CD4+ T cells
timeFrame: Baseline,12 and 24 weeks
measure: Changes in total cholesterol
timeFrame: Baseline,12 and 24 weeks
measure: Changes in LDL cholesterol
timeFrame: Baseline,12 and 24 weeks
measure: Changes in HDL cholesterol
timeFrame: Baseline,12 and 24 weeks
measure: Changes in triglycerides
timeFrame: Baseline,12 and 24 weeks
measure: Changes in body weight
timeFrame: Baseline,12 and 24 weeks
measure: Changes in fat mass
timeFrame: Baseline,12 and 24 weeks
measure: Changes in lean soft tissue
timeFrame: Baseline,12 and 24 weeks
measure: Changes in and bone mineral density
timeFrame: Baseline,12 and 24 weeks
Other outcomes:
Locations:
city: Mexico city
country: Mexico
facility: Centro de Investigaciones en Enfermedades Infecciosas
state: DF
Study officials:
affiliation: Principal investgator
name: Gustavo Reyes Teran, MD
role: PRINCIPAL_INVESTIGATOR
References: