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.: PACTR201411000930108 Date of Registration: 06/11/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Treatment of iron deficiency anemia during pregnancy
Official scientific title Lactoferrin versus Ferrous sulphate for the treatment of iron deficiency Anemia during pregnancy: A randomized clinical trial.
Brief summary describing the background and objectives of the trial This study will be conducted to evaluate the efficacy and safety of lactoferrin in comparison to ferrous sulphate for the treatment of iron deficiency anemia ( IDA) during pregnancy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Iron deficiency anemia in pregnancy,Nutritional, Metabolic, Endocrine,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 10/11/2014
Actual trial start date 15/11/2014
Anticipated date of last follow up 28/02/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 200
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
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Lactoferrin 250 mg 2 months oral intake 100
Experimental Group Ferrous sulphate 150 mg 2 months oral intake 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant women with single fetus, in the second trimester, with iron deficiency anemia (hemoglobin level <11 g/dL and ferritin levels <25 ng/dL) Women with a history of anemia due to any other causes such as chronic blood loss, hemolytic anemia, and thalassemia (including thalassemic trait), severe anemia requiring blood transfusion, bronchial asthma, clinical and/or laboratory evidence of hepatic, renal, hematologic or cardiovascular abnormalities, history of peptic ulcer, hypersensitivity to iron preparations and treatment with any other iron preparation in the last one month before study entry and suspected acute infection were excluded from the study. 18 Year(s) 34 Year(s) Female
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 02/11/2014 Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary efficacy parameter was the amount of increase in Hemoglobin concentration by 4 and 8 weeks, the adverse effects (the patients were asked to report any unusual or unpleasant symptoms during the study period) related to iron therapy and the patient compliance to treatment. 3 months
Secondary Outcome Obstetric outcome in terms of gestational age at delivery, mode of delivery, maternal complications (postpartum hemorrhage and defective lactation) and neonatal outcome (neonatal weight, admission to neonatal intensive care unit and neonatal death defined as death in the first four weeks after birth) were assessed as a secondary outcome. 4 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia University hospital 25 Yasin Abd-Elghafar street Shibin Elkom +2048 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Faculty of Medicine 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Rezk m_rezk9207@yahoo.com 00201006237186 Kafr Manawahla
City Postal code Country Position/Affiliation
Elbajour 002048 Egypt Lecturer of Obstetrics and Gynecology-Faculty of Medicine-Menoufia University
Role Name Email Phone Street address
Public Enquiries Hala Marawan Yaserkhalil1968@yahoo.com 00201003784772 kalyou
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt Lecturer in Community medicine and Public health
Role Name Email Phone Street address
Scientific Enquiries Mohamed Rezk m_rezk9207@yahoo.com 00201006237186 Kafr Manawahla
City Postal code Country Position/Affiliation
Elbajour 002048 Egypt Lecturer of Obstetrics and Gynecology-Faculty of Medicine-Menoufia University
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information