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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Conditions
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HIV

Intervention / Treatment
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* Dietary Supplement: Arthrospira platensis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: confirm Infection with HIV aged≥ 18-49 years BMI< 23 Exclusion Criteria: male under HAART pregnancy severe opportunistic infection requiring intensive medical care active smoking initiation of antioxidant vitamin therapy hyperlipidemia diabetes kidney/liver dysfunction intractable diarrhea (at least six liquid stools daily)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arthrospira platensis supplement<br> | Dietary Supplement: Arthrospira platensis<br>* Patient take 5 gram supplement per day for 12 weeks in the first phase. In the second phase the two groups receive 5 gram per day of Arthrospira platensis for 12 weeks. One group will so haved received Arthrospira platensis for 24 weeks.<br>* Other names: in the second all patients receive supp.C;|
| Placebo Comparator: Protein/Dextran supplemented<br> | Dietary Supplement: Arthrospira platensis<br>* Patient take 5 gram supplement per day for 12 weeks in the first phase. In the second phase the two groups receive 5 gram per day of Arthrospira platensis for 12 weeks. One group will so haved received Arthrospira platensis for 24 weeks.<br>* Other names: in the second all patients receive supp.C;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD4 cell account |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Anthropometric measurements (BMI, Bioimpedenz) |  | 12-24 weeks | 
| Plasma redox potential (MDA,TAOS) |  | 12-24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthrospira platensis, female HIV patient, Redox potential, Life quality, female patient infected by HIV in Yaounde: Cameroon, Yaounde