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

• Sponsor: Frank Winter (Other)
• Overall Status: Completed
• CT.gov ID: NCT01084382
• Collaborator: Centre Pasteur du Cameroun (Other)
• Enrollment: 70
• Locations: 2
• Arms: 2
• Duration (Months): 5.3
• Patients Per Site: 35
• Patients Per Site Per Month: 6.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV	Dietary Supplement: Arthrospira platensis	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Jun 10, 2010
• Actual Study Completion Date: Sep 10, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. CD4 cell account [12 weeks]

Secondary Outcome Measures

1. Individual Dietary Diversity Score (IDDS) [12-24 weeks]

2. Quality of life perception (WHOQOL-HIV) [12-24 weeks]

3. immune status (CD3+, CD8+, CD38+ and IFN gamma) [12-24 wekks]

4. Anthropometric measurements (BMI, Bioimpedenz) [12-24 weeks]

5. Plasma redox potential (MDA,TAOS) [12-24 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 49 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Hopital du jours	Yaounde	Centre	Cameroon
2	"Hôpital du jours" from the Central Hospital	Yaounde		Cameroon

Sponsors and Collaborators

• Frank Winter
• Centre Pasteur du Cameroun

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Working Group Homepage

Publications

None provided.

• Responsible Party: Frank Winter, Dr., University of Giessen
• ClinicalTrials.gov Identifier: NCT01084382
• Other Study ID Numbers: JLU-AGKrawi_Spiru
• First Posted: Mar 10, 2010
• Last Update Posted: Nov 16, 2021
• Last Verified: Nov 1, 2021

• Keywords provided by Frank Winter, Dr., University of Giessen: Arthrospira platensis; female HIV patient; Yaounde; Redox potential; Life quality; female patient infected by HIV in Yaounde: Cameroon

Study Results

No Results Posted as of Nov 16, 2021