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.: PACTR202202814392581 Date of Registration: 03/02/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title ROLE OF VITAMIN D3 IN THE MANAGEMENT OF SICKLE CELL DISEASE (SCD)
Official scientific title ROLE OF VITAMIN D3 IN THE MANAGEMENT OF SICKLE CELL DISEASE (SCD): A RANDOMIZED-CONTROLLED TRIAL OF PATIENTS IN LAGOS STATE, NIGERIA
Brief summary describing the background and objectives of the trial Sickle Cell Disease is a chronic inherited hemolytic disorder that is marked by the tendency of hemoglobin molecules within red cells to polymerize and deform the red cell into a sickle (or crescent) shape, resulting in characteristic vaso-occlusive events and accelerated haemolysis. Vitamin D, also known as calciferol, comprises a group of fat-soluble seco-sterols (Vitamin D 2 and D 3 ), and aside from its great effect on bones, it also has extra‐skeletal effects on other systems such as the cardiovascular and immune systems, as well as on muscles, on the brain, and on the control of cell cycles. We are building on the existing knowledge of vitamin D3 to examine its effect in children with sickle cell disease, who typically have ischemia, immune deficiency, and reduced bone density. Most children and adults with sickle cell disease are deficient in vitamin D 3 and other nutrients. We wish to explore the administration of vitamin D 3 as a possible, safe, and cost-effective addition for the management of sickle cell disease in Nigeria and other African countries, using the patients of three hospitals as a case study. Aim: To examine the effects of oral vitamin D 3 on the quality of life of patients with sickle cell disease, as demonstrated by questionnaires and Full Blood Count (FBC) – with differentials. Objectives: We wish to 1. Determine monthly Full Blood Count (FBC) in participants on both the routine medication and vitamin D3, and comparing it with patients on the routine medication alone, and 2. Compare the perceived quality of life between sickle cell disease patients on routine medication (folic acid and paludrine), and sickle cell disease patients on both the routine medication and vitamin D3 supplements.
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 Supportive care
Anticipated trial start date 01/11/2021
Actual trial start date
Anticipated date of last follow up 02/05/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 300
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Vitamin D3 5000IU twice daily six months 5000IU of Vitamin is D3 packaged in softgels 150
Control Group Routine Medication Vitamin B-Complex: 1 tablet 2-3 times daily Proguanil: 3.5mg/kg daily Folic Acid: 1mg daily Six months The routine medication includes folic acid, vitamin B complex, and proguanil. Folic acid is needed to improve the blood folate level. It is useful in the production of heme and thus, the production of red blood cells. It is one of the routine interventions for sickle cell disease patients, approved by the concerned bodies. It is composed of eight B vitamins (B1, B2, B3, B5, B6, B7, B9, B12) and they support red blood cells production and cardiovascular health. Proguanil is an antimalarial drug and it is given to protect against constant malaria. It is one of the routine interventions for sickle cell disease patients, approved by the concerned bodies. All participants will receive the routine drugs; however, the test group will receive both the routine medications and vitamin D3 150 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age: Patients between 1 year and 12 years Gives informed consent to participate Sickle cell disease, confirmed by laboratory tests Age: < 1 year and > 12years Consume more than 1000 IU per day of vitamin D from all supplemental sources combined (individual vitamin D supplements, calcium plus vitamin D supplements, medications with vitamin D, and multivitamins) in the past 4 weeks. Unable to complete questionnaires or adhere to study requirements Presence of complications like leg ulcers, strokes, and avascular necrosis of the head of the femur Child: 6 Year-12 Year,Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 1 Year(s) 12 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
No 15/06/2021 Lagos State University Teaching Hospital Health Research Committee
Ethics Committee Address
Street address City Postal code Country
1-5, Oba-Akinjobi road, Ikeja Lagos 100271 Nigeria
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 15/02/2021 Federal Capital Territory Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Plot 1, Kapital Street, Area 11, Garki. FCT-Abuja 900234 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Rate of crises (per month) and average crises rate through the study Average Packed Cell Volume in two months one month
Secondary Outcome Rate of healthcare visits (including hospitalizations related to infections) per month Average pain level (using pain scale) in two months one month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Massey Street Childrens Hospital Massey Street, Ita-Faaji Lagos 101225 Nigeria
General Hospital Ifako Ijaye 14, College Road, Off Iju, Ifako Ijaye Lagos 100215 Nigeria
General Hospital Isolo 120, Mushin road, Oshodi, Isolo Lagos 100263 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Brain and Body Foundation No 39, Suez Crescent, Abacha Estate, Wuse Zone 4 Abuja 900284 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Brain and Body Foundation No 39, Suez Crescent, Abacha Estate, Wuse Zone 4 Abuja 900284 Nigeria Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
National Sickle Cell Centre Ishaga Road, Idi-Araba, Surulere Lagos Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adedayo Ajibade david.wordquest@gmail.com +2348102007700 Plot 1171, Adebayo Adedeji Crescent, Utako
City Postal code Country Position/Affiliation
Abuja Nigeria Principal Investigator
Role Name Email Phone Street address
Public Enquiries James Umeadi james@brainandbodyfoundation.org +2348034377303 Plot 1171, Adebayo Adedeji Crescent, Utako
City Postal code Country Position/Affiliation
Abuja Nigeria Operations Manager
Role Name Email Phone Street address
Scientific Enquiries Solomon Adomi solomon@brainandbodyfoundation.org +2348096921421 16B, Chief Augustine Anozie Street, Lekki Phase 1
City Postal code Country Position/Affiliation
Lagos Nigeria Research Assistant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification Informed Consent Form,Study Protocol Immediately following publication, No end date It is open to anyone wishing to access the 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