" Arthrospira Platensis" as Nutrition Supplementation for Female Adult Patients Infected by HIV in Yaoundé Cameroon
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- CD4 cell account
研究概览
简要总结
Early interests in Arthrospira p. (Spirulina) were based on its high source of protein. Recently, it has drawn attention for its therapeutic effects including anticancer properties, antiviral and antibacterial properties as well as improvement of the immune system.
The aim of this study is to investigate the effect of a daily supplementation with Spirulina for adult wife living with HIV/AIDS in Yaoundé.
详细描述
Several studies suggest that the micronutrient status determines the progression of the HIV infection to AIDS. This phenomenon may be explained by a vicious cycle of malnutrition and infection. Here, the immune system needs energy and micronutrients to adequately respond to infection. Early interests in Arthrospira p. (Spirulina) were based on its high source of protein. Recently, it has drawn attention for its therapeutic effects including reduction of blood cholesterol, nephrotoxicity, anticancer properties, radiation protection, antiviral and antibacterial properties as well here improvement of the immune system.
The aim of the three months Randomized, double blind and placebo Controlled Trial (RCT) is to investigate the effect of a daily supplementation with Spirulina for adult wife living with HIV/AIDS in Yaoundé. The trial will be experimental, prospective, and longitudinal on 70 patients. The study consists of two periods of three months.
The primary objective is to evaluate the efficacy of Spirulina on CD4+ T-lymphocyte count and the viral load during the RCT. The second objective is to confirm the effect of Spirulina on nutritional status markers: albumin, iron anemia, bioimpendenz, and BMI. The documentation of the nutritional marker will depict the restorative potential of Spirulina on patients with advanced HIV infection. Further data collected within a 24-hour recall will inform about the Individual Dietary Diversity Score. Explorative objective is the following of three disease outcomes of an HIV infection at four different time points, at t=0, 3, 6 months, and 1 month after the trial. The three explorative outcomes are the immune status with CD3+, CD8+, CD38+ and IFN gamma, the oxidative status, and the patient's quality of life.
This trial will end by August 2010.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 49 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •confirm Infection with HIV
- •aged≥ 18-49 years
排除标准
- •under HAART
- •pregnancy
- •severe opportunistic infection requiring intensive medical care
- •active smoking
- •initiation of antioxidant vitamin therapy
- •hyperlipidemia
- •kidney/liver dysfunction
- •intractable diarrhea (at least six liquid stools daily)
研究组 & 干预措施
Protein/Dextran supplemented
干预措施: Arthrospira platensis (Dietary Supplement)
Arthrospira platensis supplement
干预措施: Arthrospira platensis (Dietary Supplement)
结局指标
主要结局
CD4 cell account
时间窗: 12 weeks
次要结局
- Individual Dietary Diversity Score (IDDS)(12-24 weeks)
- Quality of life perception (WHOQOL-HIV)(12-24 weeks)
- immune status (CD3+, CD8+, CD38+ and IFN gamma)(12-24 wekks)
- Plasma redox potential (MDA,TAOS)(12-24 weeks)
- Anthropometric measurements (BMI, Bioimpedenz)(12-24 weeks)
研究者
Frank Winter
Dr.
University of Giessen
