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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03421314
• Other study ID #: C21-16
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: January 1, 2020

Study information

• Verified date: January 2019
• Source: Instituto Nacional de Enfermedades Respiratorias
• Contact: Ivan Osuna Padilla, MD
• Phone: 56667985
• Email: ivan.osuna[@]cieni.org.mx
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 37
• Est. completion date: January 1, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• ART
• HIV
• Inflammation
• Metabolic Complication
• Selenium Deficiency
• Zinc Deficiency

Intervention

Dietary Supplement:
• Zinc gluconate and/or Selenium yeast
30 mg dose of zinc gluconate and/or 200 mcg of selenium yeast

Locations

Country	Name	City	State
Mexico	Centro de Investigaciones en Enfermedades Infecciosas	Mexico city	DF

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Enfermedades Respiratorias

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Counts of CD4+ T cells		Baseline,12 and 24 weeks
Secondary	Changes in fasting serum glucose		Baseline,12 and 24 weeks
Secondary	Changes in blood pressure		Baseline,12 and 24 weeks
Secondary	Changes in lipid peroxidation	Measure by TBARS	Baseline and 24 weeks
Secondary	Changes in proinflammatory cytokine profile	Measure by LUMINEX	Baseline and 24 weeks
Secondary	Changes in bone metabolism biomarkers	Changes in osteoprotegerin and RANKL levels	Baseline and 24 weeks
Secondary	Frequency of CD4+ T cells	Measure by flow cytometry	Baseline,12 and 24 weeks
Secondary	Changes in total cholesterol	in mg/dL	Baseline,12 and 24 weeks
Secondary	Changes in LDL cholesterol	in mg/dL	Baseline,12 and 24 weeks
Secondary	Changes in HDL cholesterol	in mg/dL	Baseline,12 and 24 weeks
Secondary	Changes in triglycerides	in mg/dL	Baseline,12 and 24 weeks
Secondary	Changes in body weight	in Kg	Baseline,12 and 24 weeks
Secondary	Changes in fat mass	in Kg	Baseline,12 and 24 weeks
Secondary	Changes in lean soft tissue	in Kg	Baseline,12 and 24 weeks
Secondary	Changes in and bone mineral density	g/cm3	Baseline,12 and 24 weeks