None listed
Conditions
Brief summary
Hypotheses: • Oral bovine lactoferrin is more efficacious in correcting iron deficiency anaemia among pregnant women recruited in the first trimester compared to standard iron supplements. Objectives: 1. To determine whether bovine lactoferrin is at least as effective as oral iron in treating iron deficiency anaemia among pregnant women of reproductive age. 2. To compare effectiveness of standard oral iron supplements and oral bovine lactoferrin in improving birthweight and reducing low birth weight and preterm births 3. To compare the side-effects of oral iron supplements and bovine lactoferrin 4. To compare the adherence of oral iron supplements and bovine lactoferrin Methods: We will conduct a parallel two-arm, double-blind, randomized controlled trial (RCT) in pregnant women, to compare the impact of supplementation with oral bovine lactoferrin and standard oral iron supplements on maternal iron status, and secondarily on low birth weight and preterm birth. Outcome measures/variables: The primary outcome will be the change in haemoglobin concentration from enrollment in the first trimester to third trimester (34 weeks) of pregnancy.
Interventions
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
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.
Sponsors
International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
• Pregnant women (18 years or older upto 49 years) identified at <12 weeks of gestation (i.e. in their first trimester) • Low haemoglobin <110 g/L to >70 g/L & serum ferritin <30 µg/L adjusted with CRP & AGP
Exclusion criteria
• Cases of severe anemia with haemoglobin <70 g/L will be excluded and referred to Shaheed Suhrawardy Medical College Hospital, which is the nearest tertiary level hospital for treatment • Other iron supplements taken in the one month preceding enrolment • Recent blood transfusion • Women who are currently ill with fever • History of chronic non-communicable diseases or history of TB • Women intending to move from study area before the end of the study • Ascertained allergy to milk proteins or to iron products
Outcome results
None listed