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.: PACTR202401734091130 Date of Approval: 09/01/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Natural cocoa consumption in sickle cell disease
Official scientific title Effect of natural cocoa powder consumption on blood lipids, inflammatory and metabolic biomarkers in sickle cell patients at the Ghana Institute of Clinical Genetics (GICG), Korle Bu Teaching Hospital
Brief summary describing the background and objectives of the trial Sickle cell disease (SCD) is an inherited disorder of globin chains that causes haemolysis and chronic organ damage. SCD is an autosomal recessive condition, and more prevalent in sub-Saharan Africa. Cardiopulmonary complications, including cardiomyopathy, diastolic dysfunction, pulmonary hypertension (PH), and sudden cardiac death are the most common causes of morbidity and mortality in sickle cell patients. Intervention studies strongly suggest that cocoa exerts a beneficial impact on cardiovascular health, through the reduction of blood pressure (BP), improvement of vascular function, modulation of lipid and glucose metabolism, anti-inflammatory effect and reduction of platelet aggregation. Aim: To determine the effect of natural cocoa powder (NCP) as dietary supplementation on blood lipids, serum determinants of inflammation and metabolic biomarkers in sickle cell patients at the Ghana Institute of Clinical Genetics, Korle-Bu Teaching Hospital. *Specific objectives* 1. To determine the prevalence of dyslipidaemia among the sickle cell patients 2. To assess the effect of natural cocoa powder intake on the blood lipids of the intervention and control group. 3. To determine the effect of natural cocoa powder intake on inflammatory (C-reactive protein, Interleukin-6) and metabolic biomarkers (fasting glucose, oxidative stress markers) of the intervention and control group. 4. To assess the effect of natural cocoa powder consumption on markers of haemolysis (Reticulocyte count, lactate dehydrogenase, haemoglobin levels of the intervention and control group.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) COCOLIM
Disease(s) or condition(s) being studied Genetic Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 05/02/2024
Actual trial start date
Anticipated date of last follow up 26/12/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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 Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Cocoa group At least 2.5g of natural unsweetened cocoa powder (approximately half a teaspoon) per day Three (3) months Participants in the intervention phase will be provided with packed sachets of natural cocoa powder purchased from the open market. Each of them will be required to drink at least 2.5g of cocoa powder dissolved in 100ml of hot water for 12 weeks in addition to their regular diet. Strategies such as regular phone calls with participants will be employed to improve engagement and reduce attrition during follow-up stages. Participants will also be educated on the importance of cocoa in improving blood lipids, reducing inflammation and improving metabolic risk factors, as well as possible challenges that they may encounter during the intervention phase. 75
Control Group Control group No intake of natural cocoa powder Three (3) months Participants in the control group will not be provided with natural cocoa powder. They will only consume their usual diet. 75 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants who are willing to be followed for the 12-week trial period will be included in the study. Sickle cell patients who are not on any lipid lowering drugs will be included in the RCT. Participants on lipid lowering medication prior to phase II will be excluded. Further, participants with complications (liver/renal conditions) will be excluded due to the high potassium content of cocoa Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 79 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 05/12/2023 University of Ghana College of Health Sciences Ethics and Protocol Review Committee
Ethics Committee Address
Street address City Postal code Country
Guggisberg Avenue Accra 233 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The main endpoint will be assessed by the mean changes in lipid profile (HDL-cholesterol and triglycerides At baseline, mid point and end point
Secondary Outcome The clinically relevant measures will be BMI, blood pressure, waist circumference, hip circumference, waist-to-hip ratio, fasting blood glucose level, C-reactive protein levels, Interleukin-6, TNF-alpha and oxidative stress biomarkers (SOD, CAT). The differences will be compared between intervention and control groups At baseline, mid point and end point
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ghana Institute of Clinical Genetics Guggisberg Avenue Accra 233 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
West African Genetics Medicine Centre P.O.Box LG 25 Legon 002333 Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Portia Nkumsah Riverson Nii Amartey Street Accra 233 Ghana Individual
COLLABORATORS
Name Street address City Postal code Country
Prof. Solomon Ofori Acquah West African Genetics Medicine Centre Accra 233 Ghana
Dr. Charles Brown University of Ghana, Legon Accra 233 Ghana
Prof. Frederick Addai University of Ghana, Legon Accra 233 Ghana
Dr. Joana Ainuson Quampah University of Ghana, Legon Accra 233 Ghana
Dr. Ammah Benneh Akwasi Kuma Korle Bu Teaching Hospital Accra 233 Ghana
Dr. David Adjei Department of Medical Laboratory Sciences, CHS Accra 233 Ghana
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Portia Nkumsah Riverson portiadzivenu@gmail.com +233249047414 Nii Amartey street
City Postal code Country Position/Affiliation
Accra 233 Ghana Doctoral Candidate University of Ghana
Role Name Email Phone Street address
Scientific Enquiries Charles Brown cabrown@ug.edu.gh +233268203808 Korle Bu
City Postal code Country Position/Affiliation
Accra 233 Ghana Senior Lecturer University of Ghana
Role Name Email Phone Street address
Public Enquiries Frederick Addai professoraddai194@gmail.com +233244643209 Guggisberg Avenue
City Postal code Country Position/Affiliation
Accra 233 Ghana Professor University of Ghana
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The individual participant information to be shared for this study comprises a number of data point, but not limited to: a. baseline demographic information of participants. b. clinical and laboratory information taken at various time points. c. dietary information d. any additional data collected during the research period deemed relevant to this research objective. The data will be de-identified to safeguard participants' privacy and confidentiality, preventing the disclosure of any direct or indirect identifiable information to researchers. Informed Consent Form,Study Protocol IDP will be available within six months after the primary trial results are published. The data will remain accessible for sharing for a minimum of five years from the date of trial completion. . Researchers should demonstrate a legitimate scientific research purpose that aligns with the aim of this clinical trial. This comprises a wide range of research areas, including but not limited to those related to sickle cell disease pathophysiology, role of diet (polyphenols) in reducing sickle cell disease severity. b. Researchers must provide a detailed research proposal that outlines a clear plan for ethical data use, including data security and confidentiality. c. Access must be granted to both independent and institutional researchers, provided they meet the criteria mentioned above.
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