Should we treat iron deficiency anaemia of pregnancy with lactoferrin? A randomised controlled trialLactoferrin Evaluation in Anaemia in Pregnancy

Phase 2

Active, not recruiting

• Conditions: Iron Deficient Anaemia in Pregnancy; Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy; Reproductive Health and Childbirth - Childbirth and postnatal care; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12614000988651
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-15
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Female
• Target Recruitment: 907

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

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Birth Weight[At birth];Whether oral bLF therapy reduces the proportion of women with IDAP who<br>receive intravenous iron infusion according to standard protocol OR who do not<br>respond to treatment and remain anaemic at any time between 34 weeks<br>gestation and delivery.[Any time to delivery.]