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

November 8, 2021 updated by: Frank Winter

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cameroon
      • Yaounde, Cameroon
        • "Hôpital du jours" from the Central Hospital
    • Centre
      • Yaounde, Centre, Cameroon
        • Hopital du jours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CD4 cell account
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Individual Dietary Diversity Score (IDDS)
Time Frame: 12-24 weeks
12-24 weeks
Quality of life perception (WHOQOL-HIV)
Time Frame: 12-24 weeks
12-24 weeks
immune status (CD3+, CD8+, CD38+ and IFN gamma)
Time Frame: 12-24 wekks
12-24 wekks
Anthropometric measurements (BMI, Bioimpedenz)
Time Frame: 12-24 weeks
12-24 weeks
Plasma redox potential (MDA,TAOS)
Time Frame: 12-24 weeks
12-24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Frank Winter

Collaborators

Centre Pasteur du Cameroun

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

June 10, 2010

Study Completion (Actual)

September 10, 2010

Study Registration Dates

First Submitted

March 9, 2010

First Submitted That Met QC Criteria

March 9, 2010

First Posted (Estimate)

March 10, 2010

Study Record Updates

Last Update Posted (Actual)

November 16, 2021

Last Update Submitted That Met QC Criteria

November 8, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • JLU-AGKrawi_Spiru

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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