EFFECT OF ZINC SUPPLEMENTATION ON IMMUNE RECOVERY PROGRAM HIV PATIENTS WITH AN IPS MEDELLIN
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Immunological Recovery
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults suffering from HIV/AIDS, over 18 years of age with first- and second-line antiretroviral therapy.
- •Patients with two viral loads less than 40 copies/ml (viral supression) and a stable or inferior CD4 lymphocyte count.
- •Patients with body mass index over 18.5 kg/m
- •Patients without opportunistic diseases.
排除标准
- •Pregnant women.
- •Hospitalized patients with cognitive disability evaluated by a doctor.
- •Patients who are unwilling to participate.
- •Patients taking zinc supplements.
结局指标
主要结局
Immunological Recovery
时间窗: Three months
Zinc supplementation is expected to enhance the immunological response of HIV+ patients. This can be demonstrated comparing the initial analysis with the final report (3 months later).
EFFECT OF ZINC SUPPLEMENTATION ON IMMUNE RECOVERY PROGRAM HIV PATIENTS
时间窗: THREE MONTHS
Compare the variation in levels of CD4 lymphocytes at baseline and three months after surgery (zinc or placebo) in each study patient.
次要结局
未报告次要终点
研究者
Heidy Contreras
Researcher
CES University