" 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
  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

Resource links provided by NLM:


Further study details as provided by University of Giessen:

Primary Outcome Measures:
  • CD4 cell account [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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:
  • Group with supp.A
  • Group with supp.B,
  • for the first phase
  • in the second all patients receive supp.C
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:
  • Group with supp.A
  • Group with supp.B,
  • for the first phase
  • in the second all patients receive supp.C

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
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01084382

Locations
Cameroon
Hopital du jours
Yaounde, Centre, Cameroon
"Hôpital du jours" from the Central Hospital
Yaounde, Cameroon
Sponsors and Collaborators
University of Giessen
University of Yaounde 1
Centre Pasteur Cameroun: Cameroon
Programme Prévention VIH-SIDA en Afrique Centrale (PPSAC): 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 August 01, 2014