Clinical trial NCT01084382: " Arthrospira Platensis" as Nutrition Supplementation for Female Adult Patients Infected by HIV in Yaoundé Cameroon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: Arthrospira platensis
female HIV patient
Yaounde
Redox potential
Life quality
female patient infected by HIV in Yaounde: Cameroon
Lead sponsor: University of Giessen
Sponsor class: OTHER
Collaborators: name: Centre Pasteur du Cameroun
First posted: 2010-03-10
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: CD4 cell account
timeFrame: 12 weeks
Secondary outcomes:
measure: Individual Dietary Diversity Score (IDDS)
timeFrame: 12-24 weeks
measure: Quality of life perception (WHOQOL-HIV)
timeFrame: 12-24 weeks
measure: immune status (CD3+, CD8+, CD38+ and IFN gamma)
timeFrame: 12-24 wekks
measure: Anthropometric measurements (BMI, Bioimpedenz)
timeFrame: 12-24 weeks
measure: Plasma redox potential (MDA,TAOS)
timeFrame: 12-24 weeks
Other outcomes:
Locations:
city: Yaounde
country: Cameroon
facility: Hopital du jours
state: Centre
city: Yaounde
country: Cameroon
facility: "Hôpital du jours" from the Central Hospital
Study officials:
References: