None listed
Conditions
Brief summary
Hypotheses: • Oral bovine lactoferrin is at least as effective in correcting iron deficiency anaemia among non-pregnant women of reproductive age compared to standard iron supplements. Objectives: 1. To determine the optimal dose of oral bovine lactoferrin for correction and prevention of iron deficiency anaemia in women of reproductive age. 2. To determine whether bovine lactoferrin is at least as effective as oral iron in treating iron deficiency anaemia among non-pregnant women of reproductive age. 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 non-inferiority randomized controlled trial (RCT), to compare different doses of oral bovine lactoferrin with standard oral iron supplements in non-pregnant anaemic women of reproductive age to determine the appropriate dose of bovine lactoferrin, and demonstrate it is safe and as effective as standard oral iron supplements in treating iron deficiency anaemia. Outcome measures/variables: The primary outcome will be the change in haemoglobin concentration from baseline to the end of the twelfth week of treatment.
Interventions
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 iii) standard oral iron supplements (60mg elemental iron). The intervention (each capsule once daily) will be continued for 3 months. Study personnel (field imple
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 iii) standard oral iron supplements (60mg elemental iron). 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
• Age 18 through 49 years • Non-lactating and non-pregnant • Haemoglobin <120 g/L, & serum ferritin level <30 µg/L corrected with C-reactive protein (CRP) & a1-acid glycoprotein (AGP) (1, 40).
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 within 2 months of enrolment • Reported allergy to milk proteins or to iron products
Outcome results
None listed