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

NCT ID: NCT01084382

Last Updated: 2021-11-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2010-09-10

Brief 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.

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.

Conditions

HIV

Keywords

Arthrospira platensis; female HIV patient; Yaounde; Redox potential; Life quality; female patient infected by HIV in Yaounde: Cameroon

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Arthrospira platensis supplement

Group Type: ACTIVE_COMPARATOR

Arthrospira platensis

Intervention Type: 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.

Protein/Dextran supplemented

Group Type: PLACEBO_COMPARATOR

Arthrospira platensis

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Group with supp.A; Group with supp.B,; for the first phase; in the second all patients receive supp.C

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Pasteur du Cameroun

OTHER

Sponsor Role: collaborator

Frank Winter

OTHER

Sponsor Role: lead

Responsible Party

Frank Winter

Dr.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hopital du jours

Yaoundé, Centre Region, Cameroon

"Hôpital du jours" from the Central Hospital

Yaoundé, , Cameroon

Countries

Cameroon

Other Identifiers

JLU-AGKrawi_Spiru

Identifier Type: -

Identifier Source: org_study_id