Assessing the appropriate dose and efficacy of bovine lactoferrin to correct iron deficiency anaemia in pregnancy: A community-based randomized controlled trial in Mirpur, Dhaka

• Register: ANZCTR
• Last refreshed on: 9 January 2018
• Main ID: ACTRN12617001634369
• Date of registration: 15/12/2017
• Prospective Registration: Yes
• Primary sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
• Public title: Assessing the appropriate dose and efficacy of bovine lactoferrin to correct iron deficiency anaemia in pregnancy: A community-based randomized controlled trial in Mirpur, Dhaka
• Scientific title: Assessing the appropriate dose and efficacy of bovine lactoferrin to correct iron deficiency anaemia in pregnancy: A community-based randomized controlled trial in Mirpur, Dhaka
• Date of first enrolment: 18/03/2018
• Target sample size: 608
• Recruitment status: Not yet recruiting
• URL: http://www.anzctr.org.au/ACTRN12617001634369.aspx
• Study type: Interventional
• Study design: Randomised controlled trial Parallel
• Phase: Not Applicable

Health Condition(s) or Problem(s) studied

Iron Deficiency Anemia

Intervention(s)

We will conduct a parallel, double-blind, individually randomized, controlled trial of i) oral bovine lactoferrin (200mg or 400mg [as identified in the preceding 'Part 1' trial to find the effective dose for anemia correction]) compared to ii) standard oral iron supplements in anaemic pregnant women (haemoglobin <120 g/L & serum ferritin <30 µg/L) to assess impact on haemoglobin & iron status. The intervention (each capsule once daily) will be started as soon as pregnancy is detected and will be continued throughout pregnancy till delivery. Study personnel (field implementer and study physicians) will have monthly contacts with the enrolled women for monitoring compliance to intervention.
In the part 1 trial , we will conduct a non-inferiority, double blind, individually randomized controlled trial in non-pregnant women of reproductive age with iron deficiency anaemia (haemoglobin <120 g/L & serum ferritin <30 µg/L) to assess the haemoglobin and iron status in response to i) 200mg oral bovine lactoferrin, ii) 400mg of oral bovine lactoferrin and iii) standard oral iron supplements (60mg elemental iron). The aim of Part 1 trial is to find out the effective dose of bovine Lactoferrin (200 mg or 400mg) for anaemia correction compared to standard iron supplementation. The intervention (each capsule once daily) will be continued for 3 months. Study personnel (field implementer and study physicians) will have monthly contacts with the enrolled women for monitoring compliance to intervention.