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.: PACTR202106811797550 Date of Registration: 02/06/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Blood donation and Iron supplementation in Nigeria : THE RANFERON STUDY
Official scientific title Iron supplementation and blood donation in Nigeria: Effect on haemoglobin, red cell indices, and iron stores – The Ranferon study
Brief summary describing the background and objectives of the trial Iron deficiency anaemia is an important limiting factor to a sustainable supply of blood units especially in low and middle income countries (LMIC). Blood transfusion practice in Nigeria is poorly developed and structured with paucity of voluntary non-remunerated blood donors (VNRD) and high rate of donor deferrals resulting from low haemoglobin (Hb) levels. This study aimed to assess the effect of daily supplementation of iron using Ranferon-12 on hemoglobin (Hb) level, red blood cell (RBC) indices, iron level, ferritin level and Hb recovery in Nigerian blood donors
Type of trial CCT
Acronym (If the trial has an acronym then please provide) Ranferon Study
Disease(s) or condition(s) being studied Haematological Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 04/02/2020
Actual trial start date 02/03/2020
Anticipated date of last follow up 20/04/2020
Actual Last follow-up date 30/07/2020
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 90
Recruitment status Completed
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
Crossover: all participants receive all interventions in different sequence during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group None None 6 weeks . The control group were blood donors who did not donate blood at the time of recruitment and didn't receive oral ranferon for 6 weeks 30 Placebo
Experimental Group Oral Ranferon I capsule oral Ranferon TM daily and 100mg ascorbic acid 6 weeks The test group after successful donation of one unit of whole blood, were placed on daily iron supplement using Ranferon TM. Each capsule of Ranferon TM contains 305mg ferrous fumarate equivalent to 100mg elemental iron, Cyanocobalamin 5mcg, folic acid 0.75mg and Zinc sulphate 5mg. They received one capsule of Ranferon TM and 100mg of ascorbic acid daily for six weeks. Self-reports on the GIT side effects were also collected 60
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Blood donors aged from 18-65 years Pregnancy Those on iron supplements including multivitamins containing iron and refuse to stop do so for the 6 weeks of the study, Those with baseline ferritin >300 ug/L (to exclude individuals with hemochromatosis} w Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 08/01/2020 UNTH HREC
Ethics Committee Address
Street address City Postal code Country
KM 22 Enugu PortHarcourt Expressway Ituku Ozalla Enugu Ituku-Ozalla 234 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measure is effect of 6 weeks daily iron supplementation on the recovery time of haemoglobin levels, red cell indices and iron stores post donation of one unit of whole blood. One hour after donation of a unit of blood and 6 weeks on oral Ranferon
Secondary Outcome The secondary outcomes were participants’ adherence and compliance to iron supplementation dosage using Modified Morisky score (MMS) and self-reported GIT side effects of RanferonTM. After 6 weeks on oral Ranferon
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Nigeria Teaching Hospital KM 22 Enugu -PortHarcourt Expressway Ituku Ozalla Enugu 234 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Sun Pharmaceuticals Nigeria Limited 1st Floor Abimbola House, 24 Abimola Street Ilasamaja Isolo Lagos 234 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Sun Pharmaceuticals Nigeria Limited 1st Abimbola House, 24 Abimbola Street Ilasmaja Isolo Lagos 234 Nigeria Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Theresa Nwagha theresa.nwagha@unn.edu.ng +2347065483794 Km 24 Enugu Port-Harcourt Expressway Ituku Ozalla
City Postal code Country Position/Affiliation
Enugu 400001 Nigeria Consultant
Role Name Email Phone Street address
Scientific Enquiries Angela Ugwu angelao.ugwu@unn.edu.ng +2348035023310 KM 22 Enugu Port Harcourt Expressway UNTH Ituku Ozalla
City Postal code Country Position/Affiliation
Enugu 234 Nigeria Consultant
Role Name Email Phone Street address
Public Enquiries Jerry Egbeaso egbeasojerry@gmail.com 2348037399094 KM 22 Enugu Port-harcourt Expressway UNTH Ituku Ozalla
City Postal code Country Position/Affiliation
Enugu 400001 Nigeria Research assistant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Patient data will be de-identified and stored encrypted in a passworded computer. The de-identified data will be publicly available for 2 years on the trial website. De-identified data will also be stored in highly secured clouding computing Informed Consent Form,Statistical Analysis Plan,Study Protocol The Informed Consent Form will be redacted before sharing it publicly. Patient identifiers will be removed from all documents for public access Open access to de-identified data set which can be used for any analysis in blood donors
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