Condition category
Infections and Infestations
Date applied
31/05/2007
Date assigned
17/08/2007
Last edited
17/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jean Bosco Ouedraogo

ORCID ID

Contact details

Institut de Recherche en Sciences de la Santé
Direction Régionale de l'Ouest
399
Avenue de la Liberté
01 BP 545 Bobo-Dioulasso 01
Bobo-Dioulasso
545
Burkina Faso
+226 20 98 18 80
jbouedraogo.irss@fasonet.bf

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Daily Spirulina platensis supplementation can improve clinical, nutritional and immunobiological status of HIV infected patients.

Ethics approval

Institutional Ethics Committee of Centre Muraz (Institut de Recherche en Sciences de la Santé [IRSS]), approved on 20 December 2005 (ref: 022/2005/CEI-CM)

Study design

Double-blind randomized controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

HIV / AIDS

Intervention

Group 1: 60 Patients with 200 CD4/µl of peripheric blood or lower (patients who are currently receiving antiretroviral treatment)
Sub-group 1 (30 patients): four capsules (a capsule contains 420 mg of spiruline) three times daily per os (orally) for each patient for 12 months
Sub-group 2 (30 patients): The same number of capsules as in sub-group 1 but placebo instead of active supplement

Group 2: 60 Patients with 200 < CD4 < 400 (patients who are currently receiving antiretroviral treatment)
Sub-group 1 (30 patients): four capsules (a capsule contains 420 mg of spiruline) three times daily per os for each patient for 12 months
Sub-group 2 (30 patients): The same number of capsules as in sub-group 1 but placebo instead of active supplement

Group 3: 60 Patients with CD4 >400 (some of these patients are currently receiving antiretroviral treatment)
Sub-group 1 (30 patients): four capsules (a capsule contains 420 mg of spiruline) three times daily per os for each patient for 12 months
Sub-group 2 (30 patients): The same number of capsules as in sub-group 1 but placebo instead of active supplement

Each included patient in the trial will be followed up monthly by a physician.
Anthropometric parameters of the participants will be measured monthly and their CD4, viral load, hematological and biochemical parameters will be measured semestrially.

Intervention type

Drug

Phase

Not Specified

Drug names

Spirulina platensis

Primary outcome measures

The impact of active daily supplementation of Spirulina platensis on the clinical, nutritional and immunological status of HIV infected patients will be assessed by the following:
1. Measurement of CD4, viral load, hematological and biochemical parameters at the start, 6 and 12 months of trial
2. Monthly measurement of anthropometric parameters

Secondary outcome measures

No secondary outcome measures

Overall trial start date

20/05/2006

Overall trial end date

20/01/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. HIV infected
2. At least 18 years old
3. Willing to be followed up for at least 12 months
4. Informed consent to be provided by the patient

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

180

Participant exclusion criteria

1. Patients who do not consent to be involved in the trial
2. Under the age of 18 years
3. Patients who are pregnant
4. Cardiopathy or cancer
5. Currently receiving Spirulina platensis spplementation

Recruitment start date

20/05/2006

Recruitment end date

20/01/2008

Locations

Countries of recruitment

Burkina Faso

Trial participating centre

Institut de Recherche en Sciences de la Santé
Bobo-Dioulasso
545
Burkina Faso

Sponsor information

Organisation

Ministry of Health of Burkina Faso, Drug Directorate (DGPML)

Sponsor details

Projet Spiruline Nayalgue
S/C Pr Jean-Baptiste Nikiema
Ouagadougou
03 BP 7009 Ouaga
Burkina Faso
+226 50 32 46 60 / 61
jbnikiema@yahoo.fr

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Ministry of Health of Burkina Faso, Drug Directorate (DGPML)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes