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Trial registered on ANZCTR


Registration number
ACTRN12614000988651
Ethics application status
Approved
Date submitted
5/09/2014
Date registered
15/09/2014
Date last updated
20/01/2022
Date data sharing statement initially provided
7/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Should we treat iron deficiency anaemia of pregnancy with lactoferrin? A randomised controlled trial
Lactoferrin Evaluation in Anaemia in Pregnancy
Scientific title
Should we treat iron deficiency anaemia of pregnancy with lactoferrin? A randomised controlled trial
Secondary ID [1] 285293 0
nil
Universal Trial Number (UTN)
U1111-1161-3807
Trial acronym
LEAP-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Iron Deficient Anaemia in Pregnancy 292961 0
Condition category
Condition code
Reproductive Health and Childbirth 293254 293254 0 0
Fetal medicine and complications of pregnancy
Reproductive Health and Childbirth 293255 293255 0 0
Childbirth and postnatal care
Diet and Nutrition 293310 293310 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Bovine Lactoferrin 200 mg capsules once a day

Duration of treatment: from enrolment (after 12 weeks gestation) until delivery;
Adherence monitored via monthly questions on compliance.
Intervention code [1] 290194 0
Treatment: Other
Comparator / control treatment
Iron Sulphate 80mg capsules once a day.

Duration of treatment: from enrolment (after 12 weeks gestation) until delivery;
Adherence monitored via monthly questions on compliance
Control group
Active

Outcomes
Primary outcome [1] 293107 0
Birth Weight
Timepoint [1] 293107 0
At birth
Primary outcome [2] 293146 0
Whether oral bLF therapy reduces the proportion of women with IDAP who
receive intravenous iron infusion according to standard protocol OR who do not
respond to treatment and remain anaemic at any time between 34 weeks
gestation and delivery.
Timepoint [2] 293146 0
Any time to delivery.
Secondary outcome [1] 310344 0
proportion <10th centile for birth weight
Timepoint [1] 310344 0
at birth
Secondary outcome [2] 310345 0
proportion born <37 weeks gestation
Timepoint [2] 310345 0
at birth
Secondary outcome [3] 310346 0
proportion with birth weight <2500 g
Timepoint [3] 310346 0
at birth
Secondary outcome [4] 310347 0
maternal Hb between 110-130 g/L with normal iron saturation and serum ferritin assessed via blood tests
Timepoint [4] 310347 0
at birth
Secondary outcome [5] 310348 0
maternal haemoconcentration (Hb >130 g/L) assessed via blood tests
Timepoint [5] 310348 0
at birth
Secondary outcome [6] 310349 0
duration of pregnancy
Timepoint [6] 310349 0
at birth
Secondary outcome [7] 310350 0
change in health related quality of life (HRQoL) using SF12v2 and AQoL8D
Timepoint [7] 310350 0
baseline, 30days and 6 weeks after birth
Secondary outcome [8] 333982 0
Neonatal iron status. This will be assessed using cord blood sample taken at birth.
Timepoint [8] 333982 0
At birth
Secondary outcome [9] 333983 0
change in maternal Intraleukin 6 [IL-6] concentration between trial entry and 30 days later. This will be assessed using spare blood from the iron studies.
Timepoint [9] 333983 0
30 days after treatment start
Secondary outcome [10] 333984 0
Duration of breastfeeding
Timepoint [10] 333984 0
12months after birth
Secondary outcome [11] 333985 0
Tolerability and maternal adverse effects. Midwifery staff will ask mother tolerability questions such as nausea, constipation etc, monthly until end of treatment. Questions will be in person at routine antenatal visits or over the phone,
Timepoint [11] 333985 0
To treatment end
Secondary outcome [12] 333986 0
Change in maternal Hb concentration. Hb levels will be assessed using blood samples
Timepoint [12] 333986 0
From trial entry to 30 days later and closest to delivery

Eligibility
Key inclusion criteria
Pregnant women with mild/moderate IDAP [Hb 70 -110 g/L] and gestation <30 weeks and >12 weeks
OR
Pregnant women likely to develop IDAP [Hb 111-115 g/L and serum ferritin <20micrograms/L ] and gestation <30 weeks and >12 weeks
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Contraindications to bLF or FeSO4
2. Severe anaemia needing intravenous iron according to local protocol (Hb <70 g/L)
3. Prior treatment with intravenous iron within 30 days
4. Any allergy to milk proteins or to iron products

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)
Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
5/01/2015
Actual
25/09/2015
Date of last participant enrolment
Anticipated
Actual
27/10/2021
Date of last data collection
Anticipated
31/03/2023
Actual
Sample size
Target
900
Accrual to date
Final
907
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment outside Australia
Country [1] 24237 0
Pakistan
State/province [1] 24237 0
Karachi

Funding & Sponsors
Funding source category [1] 289913 0
Government body
Name [1] 289913 0
National Health and Medical Research Council (NHMRC)
Country [1] 289913 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Locked Bag 77
Camperdown
NSW 1450
Country
Australia
Secondary sponsor category [1] 288604 0
None
Name [1] 288604 0
Address [1] 288604 0
Country [1] 288604 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291632 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 291632 0
Ethics committee country [1] 291632 0
Australia
Date submitted for ethics approval [1] 291632 0
29/08/2014
Approval date [1] 291632 0
22/09/2014
Ethics approval number [1] 291632 0
HREC/14/HNE/294
Ethics committee name [2] 297482 0
Human Research Ethics Committee Tasmania Network
Ethics committee address [2] 297482 0
Ethics committee country [2] 297482 0
Australia
Date submitted for ethics approval [2] 297482 0
Approval date [2] 297482 0
21/01/2015
Ethics approval number [2] 297482 0
H0014593

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51258 0
Prof William Tarnow-Mordi
Address 51258 0
NHMRC Clinical Trials Centre
University of Sydney
Locked Bag 77
Camperdown, NSW 1450
Country 51258 0
Australia
Phone 51258 0
+61 2 9562 5000
Fax 51258 0
Email 51258 0
leap.study@sydney.edu.au
Contact person for public queries
Name 51259 0
William Tarnow-Mordi
Address 51259 0
NHMRC Clinical Trials Centre
University of Sydney
Locked Bag 77
Camperdown, NSW 1450
Country 51259 0
Australia
Phone 51259 0
+61 2 9562 5000
Fax 51259 0
Email 51259 0
leap.study@sydney.edu.au
Contact person for scientific queries
Name 51260 0
William Tarnow-Mordi
Address 51260 0
NHMRC Clinical Trials Centre
University of Sydney
Locked Bag 77
Camperdown, NSW 1450
Country 51260 0
Australia
Phone 51260 0
+61 2 9562 5000
Fax 51260 0
Email 51260 0
leap.study@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Please refer to the NHMRC Clinical Trials Centre data sharing statement and policy.


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.