" Arthrospira Platensis" as Nutrition Supplementation for Female Adult Patients Infected by HIV in Yaoundé Cameroon
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Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV |
Dietary Supplement: Arthrospira platensis |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Supportive Care |
- CD4 cell account [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- Individual Dietary Diversity Score (IDDS) [ Time Frame: 12-24 weeks ] [ Designated as safety issue: No ]
- Quality of life perception (WHOQOL-HIV) [ Time Frame: 12-24 weeks ] [ Designated as safety issue: No ]
- immune status (CD3+, CD8+, CD38+ and IFN gamma) [ Time Frame: 12-24 wekks ] [ Designated as safety issue: No ]
- Anthropometric measurements (BMI, Bioimpedenz) [ Time Frame: 12-24 weeks ] [ Designated as safety issue: No ]
- Plasma redox potential (MDA,TAOS) [ Time Frame: 12-24 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 70 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | September 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Arthrospira platensis supplement |
Dietary Supplement: Arthrospira platensis
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. Other Names:
|
| Placebo Comparator: Protein/Dextran supplemented |
Dietary Supplement: Arthrospira platensis
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. Other Names:
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 49 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations| Cameroon | |
| Hopital du jours | |
| Yaounde, Centre, Cameroon | |
| "Hôpital du jours" from the Central Hospital | |
| Yaounde, Cameroon | |
More Information
Additional Information:
No publications provided
| Responsible Party: | Dr. Marcel Azabji Kenfack, Dep. of Physiologie, Faculty of Medicine and Biomedical Sciences University Yaoundé I, Cameroon |
| ClinicalTrials.gov Identifier: | NCT01084382 History of Changes |
| Other Study ID Numbers: | JLU-AGKrawi_Spiru |
| Study First Received: | March 9, 2010 |
| Last Updated: | March 9, 2010 |
| Health Authority: | Ethical committee of medicine, JLU-Giessen: Germany |
Keywords provided by University of Giessen:
|
Arthrospira platensis female HIV patient Yaounde |
Redox potential Life quality female patient infected by HIV in Yaounde: Cameroon |
ClinicalTrials.gov processed this record on May 23, 2013