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.: PACTR202301896425200 Date of Approval: 17/01/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title COMPARISON OF ONCE WEEKLY IRON SUPPLEMENTATION WITH DAILY REGIMEN IN PREVENTING ANAEMIA AMONG ANTENATAL ATTENDEES IN AWKA, SOUTHEAST NIGERIA– A RANDOMIZED CONTROL STUDY
Official scientific title COMPARISON OF ONCE WEEKLY IRON SUPPLEMENTATION WITH DAILY REGIMEN IN PREVENTING ANAEMIA AMONG ANTENATAL ATTENDEES IN AWKA, SOUTHEAST NIGERIA– A RANDOMIZED CONTROL STUDY
Brief summary describing the background and objectives of the trial Background: Anaemia in pregnancy is of great public health concern due to its significant contribution to maternal; and perinatal morbidity and mortality. Reducing maternal anaemia and preventing iron deficiency is thus of global importance. Objective: The objective of this study is to determine the effectiveness of weekly (120mg) and daily (60mg) supplementation in preventing iron deficiency anaemia and to compare the level of compliance and satisfaction among non-anaemic pregnant women on these two regimens. Methodology: This shall be a randomized control trial of 352 antenatal attendees selected randomly at Chukwuemeka Odumegwu Ojukwu University Teaching Hospital, Awka. The women between 14 and 24 weeks gestation shall be assigned equally to control group, 60mg elemental iron daily and study group, 120mg weekly. A paired ‘t’ shall be used to determine the difference in the mean haemoglobin and serum ferritin levels while chi square test shall be used to compare proportions with a difference considered significant at p value ≤ 0.05.
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 Treatment: Drugs
Anticipated trial start date 24/12/2022
Actual trial start date 18/01/2023
Anticipated date of last follow up 30/06/2023
Actual Last follow-up date 20/08/2023
Anticipated target sample size (number of participants) 352
Actual target sample size (number of participants) 352
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 randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Oral weekly intake of 120mg of elemental iron 120mg of elemental iron weekly 6 months Booked pregnant Women in the study group shall choose any day of the week and take to two tablets of ferrous sulphate 200mg, containing 120mg of elemental iron statim per week. They are supplied with 8 tablets every 4 weeks for the duration of the study. 176
Control Group The participants will receive 60mg of elemental iron daily 60mg of elemental iron daily 6 months The pregnant women will receive daily tablet of ferrous sulphate 176 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All consenting women with uncomplicated singleton pregnancy, registered for antenatal care (ANC) (recruited at booking) at COOUTH, Awka Women registering for ANC after 24 weeks gestation and anaemic women (Hb<11 mg/dl) shall be excluded. In addition, women with multiple pregnancies, obstetric haemorrhages in the present or past pregnancies, haemoglobinopathies such as sickle cell anaemia and women with hypertensive disorders in pregnancy shall also be excluded. Adult: 19 Year-44 Year 19 Year(s) 49 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 23/12/2022 Chukwuemeka Odumegwu Ojukwu University Teaching Hospital Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Hospital Avenue Awka 420102 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mean haemoglobin concentration and serum ferritin monthly check of the levels
Secondary Outcome Compliance , satisfaction and side effects At the end of the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Chukwuemeka Odumegwu Ojukwu University Teaching Hospital Hospital Street Awka 420102 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Prof Lawrence Ikeako COOUTH Awka 420102 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Prof. Lawrence Ikeako COOUTH, Awka 420102 Nigeria Individual
Secondary Sponsor Prof. Cyril Dim UNTH Enugu 40001 Nigeria Individual
Secondary Sponsor Dr. Leonard Ajah UNTH Enugu 40001 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Lawrence Ikeako ikeakolawrence@yahoo.com +2348037062953 COOUTH
City Postal code Country Position/Affiliation
Awka 420102 Nigeria Professor
Role Name Email Phone Street address
Public Enquiries Cyril Dim dyme72@yahoo.com +2348033341960 UNTH
City Postal code Country Position/Affiliation
Enugu 40001 Nigeria Professor
Role Name Email Phone Street address
Scientific Enquiries Leonard Ajah leonard.ajah@unn.edu.ng +2348033920789 UNTH
City Postal code Country Position/Affiliation
Enugu 40001 Nigeria Reader
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Plan to Share IPD: Yes Data obtained through this study may be provided to qualified researchers with academic interest in obstetrics and Gynaecology. Data or samples shared will be coded with the personal identification excluded. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data requests can be submitted starting 6 months after article publication and the data will be made accessible for up to 2 years. Extension can be considered on a case-by-case basis. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a study protocol,Statistical Analysis Plan ,informed consent form and clinical study report. For more information or to submit a request, please contact pactradmin@mrc.ac.za.
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