Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000357550
Ethics application status
Approved
Date submitted
5/01/2005
Date registered
5/01/2005
Date last updated
9/08/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can low dose iron be used to treat anaemia in pregnancy effectively?
Scientific title
Efficacy and side effects of iron supplements for the correction of anaemia in pregnant women: a comparison of high dose vs low dose iron
Secondary ID [1] 61 0
Perinatal Trials Registry: PTR538
Universal Trial Number (UTN)
Trial acronym
EASI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaemia in routine screening test at the end of 2nd trimester. 57 0
Condition category
Condition code
Blood 65 65 0 0
Anaemia
Reproductive Health and Childbirth 66 66 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible women are randomly allocated to one of three iron supplement groups: 20mg/day, 40mg/day or 80mg/day of iron for 8 weeks. The iron supplements were administered orally.
Intervention code [1] 1113 0
Treatment: Drugs
Comparator / control treatment
Control group
Dose comparison

Outcomes
Primary outcome [1] 96 0
Haemoglobin response
Timepoint [1] 96 0
At the end of 8 weeks treatment
Primary outcome [2] 97 0
Gastrointestinal side-effects
Timepoint [2] 97 0
At the end of 8 weeks treatment
Secondary outcome [1] 193 0
Other iron markers and pregnancy outcomes.
Timepoint [1] 193 0
At the end of 8 weeks treatment.
Secondary outcome [2] 194 0
Compliance rate at birth
Timepoint [2] 194 0

Eligibility
Key inclusion criteria
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation stratified by haemoglobin level above or below 100g/L, randomisation was generated by computer and the tablets were packed according to the randomisation and labelled sequentially.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/01/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 96 0
Charities/Societies/Foundations
Name [1] 96 0
Women's & Children's Hospital Research Foundation
Country [1] 96 0
Australia
Primary sponsor type
Individual
Name
Dr Maria Makrides
Address
Country
Secondary sponsor category [1] 73 0
Individual
Name [1] 73 0
Dr Jo Zhou
Address [1] 73 0
Country [1] 73 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Iron deficiency anaemia is a common problem in pregnancy. It is often treated with high dose iron that cause constipation, stomach cramp and inhibit zinc absorption. Despite these concerns, there are no studies designed to work out the best dose of iron to treat anaemia in pregnancy. The aim of the study is to determine the dose that is most effective for the treatment of anaemia with least side effects. Three doses of iron (20mg/d, 40mg/d and 80mg/d) will be tested, and haemoglobin response and gastrointestinal side-effects will be assessed as the primary outcome. All researchers involved in the data collection and data analysis were blinded to the group allocation of the subjects until the primary analysis was completed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36123 0
Address 36123 0
Country 36123 0
Phone 36123 0
Fax 36123 0
Email 36123 0
Contact person for public queries
Name 10302 0
Dr M Makrides
Address 10302 0
Child Nutrition Research Centre (CHRI)
1st Floor
Rieger Building
Women's & Children's Hospital
72 King William Rd
North Adelaide SA 5006
Country 10302 0
Australia
Phone 10302 0
+61 8 81616067
Fax 10302 0
+61 8 81618228
Email 10302 0
[email protected]
Contact person for scientific queries
Name 1230 0
Dr M Makrides
Address 1230 0
Child Nutrition Research Centre CHRI
1st Floor Rieger Building
Women's & Children's Hospital
72 King William Rd
North Adelaide SA 5006
Country 1230 0
Australia
Phone 1230 0
+61 8 81616067
Fax 1230 0
+61 8 81618228
Email 1230 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.