Ignite Creation Date:
2024-05-06 @ 11:04 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03421314
Status:
UNKNOWN
Last Update Posted:
2019-01-30
First Post:
2018-01-10
Brief Title:
Effect of Zinc and Selenium Supplementation on HIV Individuals on Antiretroviral Treatment
Sponsor:
Instituto Nacional de Enfermedades Respiratorias
Organization:
Instituto Nacional de Enfermedades Respiratorias
Study Overview
Official Title:
Effect of Zinc and Selenium Supplementation on Clinical and Immunological Parameters on HIV Individuals on Antiretroviral Treatment
Status:
UNKNOWN
Status Verified Date:
2019-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to evaluate the effect of zinc gluconate andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None