HIVNCT01084382
" Arthrospira Platensis" as Nutrition Supplementation for Female Adult Patients Infected by HIV in Yaoundé Cameroon
A study testing Arthrospira platensis in people with HIV, run by Frank Winter at 2 sites in Cameroon.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- HIV
- What is being tested?
- Arthrospira platensis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 2 sitesCameroon
- Study dates
- Apr 2010to 10 Sep 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- confirm Infection with HIV
- aged≥ 18-49 years
- BMI< 23
Who cannot join
- male
- under HAART
- pregnancy
- severe opportunistic infection requiring intensive medical care
- active smoking
- initiation of antioxidant vitamin therapy
Show all 10Show fewer
- hyperlipidemia
- diabetes
- kidney/liver dysfunction
- intractable diarrhea (at least six liquid stools daily)
Trial locations and contacts
2 sites in 1 country.
Cameroon2 sites
Hopital du jours
Yaoundé, Centre Region
"Hôpital du jours" from the Central Hospital
Yaoundé
About this study
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.
Read the 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
- Being tested
- Arthrospira platensis
- Keywords
- Arthrospira platensis, female HIV patient, Yaounde, Redox potential, Life quality, female patient infected by HIV in Yaounde: Cameroon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthrospira platensisDietary supplement
Also called Group with supp.A, Group with supp.B,, for the first phase, in the second all patients receive supp.C
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.
| Study group | Role | What they receive |
|---|---|---|
| Arthrospira platensis supplement | Active comparator | Not described Receives: Dietary Supplement: Arthrospira platensis |
| Protein/Dextran supplemented | Placebo comparator | Not described Receives: Dietary Supplement: Arthrospira platensis |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD4 cell account
Measured: 12 weeks
Secondary outcomes (5)
Individual Dietary Diversity Score (IDDS)
Measured: 12-24 weeks
Quality of life perception (WHOQOL-HIV)
Measured: 12-24 weeks
immune status (CD3+, CD8+, CD38+ and IFN gamma)
Measured: 12-24 wekks
Anthropometric measurements (BMI, Bioimpedenz)
Measured: 12-24 weeks
Plasma redox potential (MDA,TAOS)
Measured: 12-24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startApr 2010
- Primary completion10 Jun 2010
- Study completion10 Sep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frank Winter
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Pasteur du Cameroun
- Responsible party
- Sponsor-investigator, Frank Winter, University of Giessen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084382
- Sponsor's protocol ID
- JLU-AGKrawi_Spiru
- Status last verified
- Nov 2021
- First submitted
- 9 Mar 2010
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- " Arthrospira Platensis" as Nutrition Supplementation for Female Adult Patients Infected by HIV in Yaoundé Cameroon
- ClinicalTrials.gov ID
- NCT01084382
- Acronym / sponsor ID
- JLU-AGKrawi_Spiru
- Conditions
- HIV
- Keywords
- Arthrospira platensis, female HIV patient, Yaounde, Redox potential, Life quality, female patient infected by HIV in Yaounde: Cameroon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Frank WinterUniversity, hospital or other
- Collaborators
- Centre Pasteur du Cameroun
- Study start
- Apr 2010
- Primary completion
- 10 Jun 2010 (actual)
- Study completion
- 10 Sep 2010 (actual)
- First posted
- 10 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthrospira platensis supplement | Active comparator | Dietary Supplement: Arthrospira platensis |
| Protein/Dextran supplemented | Placebo comparator | Dietary Supplement: Arthrospira platensis |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- confirm Infection with HIV
- aged≥ 18-49 years
- BMI< 23
Key exclusion criteria (10 listed)
- male
- under HAART
- pregnancy
- severe opportunistic infection requiring intensive medical care
- active smoking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthrospira platensisAlso: Group with supp.A, Group with supp.B,, for the first phase, in the second all patients receive supp.CPatient 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. | Dietary supplement | Arthrospira platensis supplement, Protein/Dextran supplemented |
Primary outcome
CD4 cell account
Time frame: 12 weeks
5 secondary outcomes
Individual Dietary Diversity Score (IDDS)
Time frame: 12-24 weeks
Quality of life perception (WHOQOL-HIV)
Time frame: 12-24 weeks
immune status (CD3+, CD8+, CD38+ and IFN gamma)
Time frame: 12-24 wekks
Anthropometric measurements (BMI, Bioimpedenz)
Time frame: 12-24 weeks
Plasma redox potential (MDA,TAOS)
Time frame: 12-24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthrospira platensis in people with HIV, run by Frank Winter at 2 sites in Cameroon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CD4 cell account (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021.