Impact of Spirulina platensis supplementation on general health status of HIV infected patients in Burkina Faso

ISRCTN	ISRCTN83770226
DOI	https://doi.org/10.1186/ISRCTN83770226
Secondary identifying numbers	N/A

Submission date: 31/05/2007
Registration date: 17/08/2007
Last edited: 17/08/2007

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Not provided at time of registration

Contact information

Prof Jean Bosco Ouedraogo
Scientific

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

Phone	+226 20 98 18 80
Email	jbouedraogo.irss@fasonet.bf

Study information

Study design	Double-blind randomized controlled trial.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study hypothesis	Daily Spirulina platensis supplementation can improve clinical, nutritional and immunobiological status of HIV infected patients.
Ethics approval(s)	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)
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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Spirulina platensis
Primary outcome measure	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 study start date	20/05/2006
Overall study end date	20/01/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	180
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 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

Study participating centre

Institut de Recherche en Sciences de la Santé

Bobo-Dioulasso
545
Burkina Faso

Sponsor information

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

Projet Spiruline Nayalgue
S/C Pr Jean-Baptiste Nikiema
Ouagadougou
03 BP 7009 Ouaga
Burkina Faso

Phone	+226 50 32 46 60 / 61
Email	jbnikiema@yahoo.fr
"ROR"	https://ror.org/03h83vk17

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan