Effect of Zinc and Selenium Supplementation on Clinical and Immunological Parameters on HIV+ Individuals on Antiretroviral Treatment.
试验速览
- 阶段
- 不适用
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Changes from baseline in zinc and selenium plasmatic levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Triple
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •HIV infected
- •>200 CD4+ cells/mL
- •>2 years under antiretroviral treatment
- •>2 years under virology control (HIV RNA <40 copies/mL)
排除标准
- •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.
研究组 & 干预措施
Control
Participants in this arm will not take supplementation as a control.
Zinc
Participants in this arm will take a daily 30 mg dose of zinc gluconate during 6 months
干预措施: Zinc gluconate and/or Selenium yeast (Dietary Supplement)
Selenium
Participants in this arm will take a daily 200 mcg of selenium yeast during 6 months
干预措施: Zinc gluconate and/or Selenium yeast (Dietary Supplement)
Zinc + Selenium
Participants in this arm will take a daily 30 mg dose of zinc gluconate + 200 mcg of selenium yeast during 6 months
干预措施: Zinc gluconate and/or Selenium yeast (Dietary Supplement)
结局指标
主要结局
Changes from baseline in zinc and selenium plasmatic levels
时间窗: Baseline and 24 weeks
We evaluated the effects of zinc (30mg/d) and selenium (200μg/d) supplementation on plasma zinc and selenium levels.
次要结局
- Counts of CD4+ T cells(Baseline,12 and 24 weeks)
- Changes in LDL cholesterol(Baseline,12 and 24 weeks)
- Changes in triglycerides(Baseline,12 and 24 weeks)
- Frequency of CD4+ T cells(Baseline,12 and 24 weeks)
- Changes in HDL cholesterol(Baseline,12 and 24 weeks)
- Changes in fat mass(Baseline,12 and 24 weeks)
- Changes in fasting serum glucose(Baseline,12 and 24 weeks)
- Changes in and bone mineral density(Baseline,12 and 24 weeks)
- Changes in lipid peroxidation(Baseline and 24 weeks)
- Changes in proinflammatory cytokine profile(Baseline and 24 weeks)
- Changes in total cholesterol(Baseline,12 and 24 weeks)
- Changes in body weight(Baseline,12 and 24 weeks)
- Changes in blood pressure(Baseline,12 and 24 weeks)
- Changes in bone metabolism biomarkers(Baseline and 24 weeks)
- Changes in lean soft tissue(Baseline,12 and 24 weeks)
研究者
Gustavo Reyes-Teran
Principal Investigator
Instituto Nacional de Enfermedades Respiratorias