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临床试验/NCT01084382
NCT01084382已完成不适用

" Arthrospira Platensis" as Nutrition Supplementation for Female Adult Patients Infected by HIV in Yaoundé Cameroon

Frank Winter2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2010年4月1日最近更新:
适应症
干预措施

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

Placebo Comparator

干预措施: Arthrospira platensis (Dietary Supplement)

Arthrospira platensis supplement

Active Comparator

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

发起方
Frank Winter
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Frank Winter

Dr.

University of Giessen

研究点 (2)

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