Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202211821139161 Date of Approval: 28/11/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Spirulina plantensis supplementation reduces anemia, inflammation and improve nutritional status of sickle cell aneamia patients
Official scientific title Spirulina plantensis supplementation reduces anemia, inflammation and improve nutritional status of sickle cell aneamia patients
Brief summary describing the background and objectives of the trial Background: Mortality associated with Sickle cell anemia (SCA) remains higher in Cameroon. Previous study have shown that SCA patients are malnourished. Spirulina platensis (S.platensis), (cyanobacteria) is commonly produced in several countries and Cameroon. It contains higher levels of iron among other minerals, vitamins, polyunsaturated fatty acids, protein and other antioxidant molecules. It consumption improves nutritional status of malnourished children, elders and illness people. We believed that there is a correlation between regular intake of S. platensis and the improvement both aneamia, nutritional status and inflammation in SCA patients. This study aims to investigate the effect of regular intake of S. platensis on aneamia, nutritional status and inflammation of SCA patients in Cameroon. Study design: A double blind randomized trial study will be conducted during 1 year in Yaounde and Bafoussam hospitals. Homozygous SS patients aged between 5 and 25 years followed in the hospitals will be recruited. S.platensis will be provided by “CAP-Spiruline” NGO in Nomayos Yaounde-Cameroon. Included patients will be divided into two groups after random draw: control and test groups receiving repectively 10g of Soja bean powder and 10 g of S. platensis per day. The following interventions will be done: (i)Information about the objective of the study and consent form request, (ii) filling of the questionnaire forms, 1st sampling (baseline, To) followed by administration of S. platensis/Soja been powder (iii) Administration of S. platensis and taking of clinical and anthropometrics parameters (T1), (T2) and (T3) months after To (iv). At (T4) 4 months after To blood sample will be collected after previous clinical parameters. During these follow-up, clinical parameters will be registered and blood analysed. The haematological, iron profile, inflammatory and nutritional markers will be determined. Expected results: The regular intake of S. platensis will reduce ana
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Haematological Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 05/06/2022
Actual trial start date 12/06/2022
Anticipated date of last follow up 05/12/2022
Actual Last follow-up date 12/12/2022
Anticipated target sample size (number of participants) 140
Actual target sample size (number of participants) 108
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Dynamic (adaptive) random allocation such as minimization Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Spirulina group 10g/day (Each dose was in a paquet) Four (4) months. Each participant in a group will receive a paquet 30 small paquets of 10g of spirulina platensis for 30 days. Each participant have to take 10g/day during 4 four month without interruption. Participant who take Spirulina platensis daily lest than 3 and half month will be excluded to the study. 54
Control Group Soja group 10g/day Four (4) months Each participant will received a paquet containing 30 small paquets of 10g of Soja beam powder for 30 days 54 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Will be included in this study 1- Homozygote (SS) and heterozygote SC and SF 2- Male or female 3- Aged between 2 – 35 Years old 4- Patients who approve and sign the form 1- Sickle cell patient whose iron blood level is higher than normal 2- Sickle cell patient who is taking other treatment simultaneously 3- Sickle cell patient who decided to withdraw to the study 4- Sickle cell patient who did not go through the supplementation at least 3 three and half months Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 2 Year(s) 35 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/04/2022 Regional Ethics Committee for Human Health Research
Ethics Committee Address
Street address City Postal code Country
Rue Maison de la radio Yaound Yaounde 110 Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Determination of hematological and iron profiles hemoglobin (Hb) level, mean corpuscular volume (MCV), hematocrit, mean hemoglobin content (MCHT), mean hemoglobin concentration (MCHC), concentration of blood iron and ferritin 2 times: baseline and after 4 months of supplementation of Spirulina platensis
Secondary Outcome Nutritional assessment will be done through determination of the following parameters: weight, BMI, body fat, water mass, muscle mass, bone mass, waist circumference, albumin and total protein 5 times, baseline and every months until the last month of supplementation
Secondary Outcome Determination of immunological and biochemical parameters Cell reactive , lymphocytes, monocytes, granulocytes, protein, ALAT, ASAT, Urea, creatine 2 times Baseline and after four months of supplementation of spirulina platensis
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Central Hospital of Yaounde Stree education Yaounde 120 Cameroon
Regional hospital of Bafoussam Centre Bafoussam 152 Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
PIEME Constant Anatole Total MELEN Yaounde 1364 Cameroon
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor PIEME Constant Anatole Total MELEN Yaounde 1364 Cameroon Individual
Secondary Sponsor CAP Spiruline Maison de la Nutrition Route Nkondengui Yaounde Cameroon Association or NGO
Secondary Sponsor NKWICHEU NYA Prudence Josela Emonbo Yaounde Cameroon Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Constant Anatole PIEME constant.pieme@fmsb-uy1.cm +237674551871 Total MELEN
City Postal code Country Position/Affiliation
Yaounde 110 Cameroon Laboratory of Biochemistry Faculty of Medicine and Biomedical Sciences University of Yaounde I
Role Name Email Phone Street address
Public Enquiries Prudence Josela Nya Nkwicheu pprudencebenie@yahoo.fr +237670059137 Total MELEN
City Postal code Country Position/Affiliation
Yaounde 110 Cameroon Assistant lecturer
Role Name Email Phone Street address
Scientific Enquiries Prosper Cabral Nya Biapa brbiapa@yahoo.fr +237675965283 Universite
City Postal code Country Position/Affiliation
Dschang Cameroon Researcher and Lecturer Department of Biochemistry Faculty of Science University of Dschang
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification will be available as tables, figures, pictures or appendices. Informed Consent Form,Study Protocol The data will be published in the journal between 10 to 36 months after the trials. They will also be presented to conferences. We will find open access journal so that a maximum of population and scientist should have access to these data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information