Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01084382 |
| Other study ID # |
JLU-AGKrawi_Spiru |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 2010 |
| Est. completion date |
September 10, 2010 |
Study information
| Verified date |
November 2021 |
| Source |
University of Giessen |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
