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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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30 August 2021 |
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Main ID: |
PACTR202106811797550 |
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Date of registration:
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26/05/2021 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Blood donation and Iron supplementation in Nigeria : THE RANFERON STUDY
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Scientific title:
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Iron supplementation and blood donation in Nigeria: Effect on haemoglobin, red cell indices, and iron stores – The Ranferon study |
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Date of first enrolment:
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04/02/2020 |
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Target sample size:
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90 |
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Recruitment status: |
Complete |
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URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=15897 |
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Study type:
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Interventional |
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Study design:
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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
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Phase:
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Not Applicable
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Countries of recruitment
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Nigeria
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Contacts
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Name:
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Angela
Ugwu |
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Address:
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KM 22 Enugu Port Harcourt Expressway UNTH Ituku Ozalla
234
Enugu
Nigeria |
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Telephone:
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+2348035023310 |
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Email:
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angelao.ugwu@unn.edu.ng |
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Affiliation:
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Consultant |
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Name:
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Jerry
Egbeaso |
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Address:
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KM 22 Enugu Port-harcourt Expressway UNTH Ituku Ozalla
400001
Enugu
Nigeria |
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Telephone:
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2348037399094 |
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Email:
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egbeasojerry@gmail.com |
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Affiliation:
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Research assistant |
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Key inclusion & exclusion criteria
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Inclusion criteria: Blood donors aged from 18-65 years
Exclusion criteria: 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
Age minimum:
13 Year(s)
Age maximum:
18 Year(s)
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Haematological Disorders
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Haematological Disorders
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Intervention(s)
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None
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Oral Ranferon
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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.
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Source(s) of Monetary Support
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Sun Pharmaceuticals Nigeria Limited
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Ethics review
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Status: Approved
Approval date: 08/01/2020
Contact:
maxionyimba@gmail.com
UNTH HREC
+2348034079903
maxionyimba@gmail.com
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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