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Completed

NCT Number: NCT01084382

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

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.

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Key information

Conditions

HIV

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hopital du jours, Yaoundé, Centre Region, Cameroon

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Arthrospira platensis

Dietary Supplement

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

Primary outcomes

  1. CD4 cell account

    Time frame: 12 weeks

Secondary outcomes

  1. Individual Dietary Diversity Score (IDDS)

    Time frame: 12-24 weeks

  2. Quality of life perception (WHOQOL-HIV)

    Time frame: 12-24 weeks

  3. immune status (CD3+, CD8+, CD38+ and IFN gamma)

    Time frame: 12-24 wekks

  4. Anthropometric measurements (BMI, Bioimpedenz)

    Time frame: 12-24 weeks

  5. Plasma redox potential (MDA,TAOS)

    Time frame: 12-24 weeks

Sponsors and collaborators

Lead sponsor

Frank Winter

Other

Collaborators

  • Centre Pasteur du Cameroun

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Mar 10, 2010
Registry last updated
Nov 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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