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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
University of Yaounde 1
Centre Pasteur Cameroun: Cameroon
Programme Prévention VIH-SIDA en Afrique Centrale (PPSAC): Cameroon
Information provided by:
University of Giessen
ClinicalTrials.gov Identifier:
NCT01084382
First received: March 9, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted

March 9, 2010
March 9, 2010
April 2010
June 2010   (final data collection date for primary outcome measure)
CD4 cell account [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
" Arthrospira Platensis" as Nutrition Supplementation for Female Adult Patients Infected by HIV in Yaoundé Cameroon
Not Provided

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
HIV
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:
  • Group with supp.A
  • Group with supp.B,
  • for the first phase
  • in the second all patients receive supp.C
  • Active Comparator: Arthrospira platensis supplement
    Intervention: Dietary Supplement: Arthrospira platensis
  • Placebo Comparator: Protein/Dextran supplemented
    Intervention: Dietary Supplement: Arthrospira platensis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
70
September 2010
June 2010   (final data collection date for primary outcome measure)

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)
Female
18 Years to 49 Years
No
Contact information is only displayed when the study is recruiting subjects
Cameroon
 
NCT01084382
JLU-AGKrawi_Spiru
Yes
Dr. Marcel Azabji Kenfack, Dep. of Physiologie, Faculty of Medicine and Biomedical Sciences University Yaoundé I, Cameroon
University of Giessen
  • University of Yaounde 1
  • Centre Pasteur Cameroun: Cameroon
  • Programme Prévention VIH-SIDA en Afrique Centrale (PPSAC): Cameroon
Not Provided
University of Giessen
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP