NCT01084382

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
Completed

Started Apr 2010

Shorter than P25 for not_applicable hiv

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 10, 2010

Completed
22 days until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2010

Completed
Last Updated

November 16, 2021

Status Verified

November 1, 2021

Enrollment Period

2 months

First QC Date

March 9, 2010

Last Update Submit

November 8, 2021

Conditions

HIV

Keywords

Arthrospira platensisfemale HIV patientYaoundeRedox potentialLife qualityfemale patient infected by HIV in Yaounde: Cameroon

Outcome Measures

Primary Outcomes (1)

  • CD4 cell account

    12 weeks

Secondary Outcomes (5)

  • Individual Dietary Diversity Score (IDDS)

    12-24 weeks

  • Quality of life perception (WHOQOL-HIV)

    12-24 weeks

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

    12-24 wekks

  • Anthropometric measurements (BMI, Bioimpedenz)

    12-24 weeks

  • Plasma redox potential (MDA,TAOS)

    12-24 weeks

Study Arms (2)

Arthrospira platensis supplement

ACTIVE COMPARATOR
Dietary Supplement: Arthrospira platensis

Protein/Dextran supplemented

PLACEBO COMPARATOR
Dietary Supplement: Arthrospira platensis

Interventions

Arthrospira platensisDIETARY_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.

Also known as: Group with supp.A, Group with supp.B,, for the first phase, in the second all patients receive supp.C
Arthrospira platensis supplementProtein/Dextran supplemented

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • confirm Infection with HIV
  • aged≥ 18-49 years
  • BMI\< 23

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hopital du jours

Yaoundé, Centre Region, Cameroon

Location

"Hôpital du jours" from the Central Hospital

Yaoundé, Cameroon

Location

MeSH Terms

Interventions

Population Groups

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 9, 2010

First Posted

March 10, 2010

Study Start

April 1, 2010

Primary Completion

June 10, 2010

Study Completion

September 10, 2010

Last Updated

November 16, 2021

Record last verified: 2021-11

Locations

CA(2)