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 |
| Protocol serial number | N/A |
| Sponsor | Ministry of Health of Burkina Faso, Drug Directorate (DGPML) |
| Funder | Ministry of Health of Burkina Faso, Drug Directorate (DGPML) |
- 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 of protocol
Not provided at time of registration
Contact information
Prof Jean Bosco Ouedraogo
Scientific
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 |
|---|---|
| jbouedraogo.irss@fasonet.bf |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind randomized controlled trial. |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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) |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Spirulina platensis |
| Primary outcome measure(s) |
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: |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 20/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 180 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 20/05/2006 |
| Date of final enrolment | 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
545
Burkina Faso
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
