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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01084382
Enrollment
70
Registered
2010-03-10
Start date
2010-04-30
Completion date
2010-09-10
Last updated
2021-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

Arthrospira platensis, female HIV patient, Yaounde, Redox potential, Life quality, female patient infected by HIV in Yaounde: Cameroon

Brief summary

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

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.

Interventions

DIETARY_SUPPLEMENTArthrospira 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.

Sponsors

Centre Pasteur du Cameroun
CollaboratorOTHER
Frank Winter
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 49 Years
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)

Design outcomes

Primary

MeasureTime frame
CD4 cell account12 weeks

Secondary

MeasureTime 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

Countries

Cameroon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026