Status:
UNKNOWN
Supplementing Iron and Development in Breastfed Infants (SIDBI Study)
Lead Sponsor:
Medical University of Warsaw
Conditions:
Iron Deficiency
Eligibility:
All Genders
16-18 years
Phase:
PHASE4
Brief Summary
INTRODUCTION Exclusively breastfed infants are at risk of iron deficiency. American Academy of Pediatrics (AAP) recommends iron supplementation in exclusively breastfed infants beginning at 4 months o...
Detailed Description
INTRODUCTION Iron is a nutrient of essential importance to the human organism. It takes part in energy production, oxygen transportation, and DNA synthesis and is indispensable for the development of ...
Eligibility Criteria
Inclusion
- Term singleton infants (\>37 weeks gestational age)
- Birth weight \> 2500g
- Healthy at inclusion
- Breastfed exclusively or predominantly (\>50% meals) at inclusion
- No previous iron supplementation
- No previous blood transfusion
- Informed consent given
Exclusion
- preterm delivery (\<37 weeks of gestation)
- birth weight \< 2500 g
- multiple pregnancy
- major illness or congenital anomaly
- being \<50% breastfed at the time of inclusion
- food allergy
- anaemia (Hb \<105 g/L \[10.5 g/dL\]) at inclusion, lack of informed consent
Key Trial Info
Start Date :
September 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2019
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT02242188
Start Date
September 1 2015
End Date
June 1 2019
Last Update
February 23 2017
Active Locations (1)
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1
Department of Pediatrics, The Medical University of Warsaw
Warsaw, Poland, 02091