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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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29 May 2023 |
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Main ID: |
PACTR201804003188338 |
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Date of registration:
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13/03/2018 |
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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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Spatone Trial in Pregnant Nigerian Women
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Scientific title:
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A Randomized, 28-days, Parallel-group, Equivalence Study to Compare the Effectiveness of 10mg Fe2+ Spatone Iron-Plus and 60mg Fe2+ Ferrous sulphate in Improving Haemoglobin Status of Pregnant Women in Lagos University Teaching Hospital |
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Date of first enrolment:
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04/01/2018 |
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Target sample size:
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200 |
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Recruitment status: |
Recruiting |
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URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3188 |
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Study type:
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Interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study,Randomised,Simple randomisation using a radomisation table created by a computer software program,Sealed opaque envelopes
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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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Njideka
Okubadejo |
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Address:
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Ishaga Road
100254
Surulere, Lagos
Nigeria |
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Telephone:
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+234-8023130243 |
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Email:
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njide_okubadejo@yahoo.com |
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Affiliation:
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University of Lagos/Lagos University Teaching Hospital |
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Name:
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D, J,
Akpan |
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Address:
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Ishaga Road
100254
Surulere, Lagos
Nigeria |
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Telephone:
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+234-1-585737 |
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Email:
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luthethics@yahoo.com |
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Affiliation:
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Administrative Secretary |
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Key inclusion & exclusion criteria
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Inclusion criteria: Subjects willing and able to give informed consent for participation in the trial
Pregnant women who have a singleton fetus
Aged 18 to 44 years
Gestational age between 14 and 27 weeks of pregnancy
Exclusion criteria: Pregnant women with multifetal pregnancy
History of allergy to iron containing preparation
History of chronic medical conditions such as chronic renal failure, haemoglobinopathy
History of chronic inflammatory/infectious diseases such as tuberculosis or HIV infection in pregnancy
Inability to return for follow-up visit at 4 weeks after enrolment
Severe anaemia or anaemia with clinical features of cardiac failure
Age minimum:
18 Year(s)
Age maximum:
44 Year(s)
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Haematological Disorders
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Haematological Disorders
Pregnancy and Childbirth
Anaemia in Pregnancy
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Pregnancy and Childbirth
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Anaemia in Pregnancy
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Intervention(s)
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Tablet ferrous sulphate [200mg tablet containing 60mg of elemental iron]
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Spatone iron-plus solution
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Primary Outcome(s)
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Haemoglobin concentration on day 28 post-randomization
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Secondary Outcome(s)
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Serum ferritin concentration on day 28 post-randomization
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Source(s) of Monetary Support
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Investigator-initiated
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Ethics review
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Status: Approved
Approval date: 19/06/2017
Contact:
Lagos University Teaching Hospital, Health Research Ethics Committee
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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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