Should we treat iron deficiency anaemia of pregnancy with lactoferrin? A randomised controlled trial Lactoferrin Evaluation in Anaemia in Pregnancy: LEAP-1
Should we treat iron deficiency anaemia of pregnancy with lactoferrin? A randomised controlled trial
University of Sydney
900 participants
Sep 25, 2015
Interventional
Conditions
Summary
Iron deficiency - the world’s commonest nutritional disorder affects over 2 billion people (WHO 2008), with women and children at greatest risk. This study aims to evaluate, in a randomised controlled trial (RCT), oral bovine lactoferrin (bLF) vs iron sulphate (FeSO4) in iron deficiency anaemia in pregnancy (IDAP). This study will comparerandomised groups on the following co-primary endpoints: 1) Fetal growth (birth weight for gestational age) 2) 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.
Eligibility
Inclusion Criteria3
- 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
Exclusion Criteria4
- Contraindications to bLF or FeSO4
- Severe anaemia needing intravenous iron according to local protocol (Hb <70 g/L)
- Prior treatment with intravenous iron within 30 days
- Any allergy to milk proteins or to iron products
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12614000988651