NCT02162797

Zinc Supplementation Effect on Immune Recovery in HIV Patients

EFFECT OF ZINC SUPPLEMENTATION ON IMMUNE RECOVERY PROGRAM HIV PATIENTS WITH AN IPS MEDELLIN

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: CES University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

INTRODUCTION: An adequate zinc supplementation is essential for a good immunological function. However, zinc deficiency is seen in more than 50% of adults infected with HIV. The safety and efficiency of zinc supplements in the progression of HIV is evaluated in the short-term. HYPOTHESIS Null hypothesis: Zinc supplementation does not improve the immunological recovery of HIV patients after three months of daily consumption. Alternate hypothesis: Zinc supplementation improves the immunological recovery of HIV patients after three months of daily consumption

Detailed description

GOAL: To assess the effect of zinc supplementation in the natural history of HIV, emphasizing on the immunological recovery of patients in a health care provider program in Medellín in 2012. METHODS: A prospective, randomized, double-blind, controlled clinical trial will be conducted. The selected group will consist of male and female patients over 18 years of age, who comply with the inclusion criteria, with digital clinical history, in an HIV/AIDS program of a health care provider in Medellín. They will receive zinc supplements for 3 months. A comparison will be made between the immunological recovery among those patients taking the zinc supplement and those who are not. The CD4 lymphocytes value will be taken as an independent variable.

Conditions

• HIV
• AIDS
• Immunological Deficiency
• Inadequate Immune Recovery
• Viral Replication

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Zinc supplementation	Intervention group A: Patients who will orally receive zinc for 3 months.
DIETARY_SUPPLEMENT	Placebo supplementation	Intervention Group B: Patients who will orally receive a placebo for 3 months.

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2014-06-13
• Last updated: 2014-06-13

Locations

1 site across 1 country: Colombia