Iron Deficiency Clinical Trial
— SIDBIOfficial title:
Effect of Iron Supplementation on Psychomotor Development of Non-anemic Exclusively or Predominantly Breastfed Infants: Randomized, Double-blind, Placebo-controlled Trial.
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 of age. Uncertainty exists regarding the effects of iron
supplementation during infancy on neurodevelopmental outcomes in the absence of anemia.
AIM To establish whether psychomotor and mental development is influenced by early iron
supplementation in healthy, non-anemic, exclusively or predominantly breastfed infants.
METHODS Healthy term newborns will be recruited shortly after birth. If predominantly
breastfed (>50% daily feedings) and non-anemic at 4 months, they will be randomized to
receive either an iron supplement (approx.1mg/kg/day) or placebo until 9 months of age.
Participants will be assessed with use of Bayley Scales of Infant and Toddler Development
(Bayley III) at 12, 24 and 36 months of age.
Status | Recruiting |
Enrollment | 220 |
Est. completion date | June 2019 |
Est. primary completion date | January 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 16 Weeks to 18 Weeks |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Poland | Department of Pediatrics, The Medical University of Warsaw | Warsaw |
Lead Sponsor | Collaborator |
---|---|
Medical University of Warsaw |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Psychomotor development | Psychomotor development will be assessed with the Bayley Scales of Infant and Toddler Development (Bayley III or BSID III) at 12 and 24 months of age. | 12, 24 and 36 months of age | |
Secondary | Hematological and iron status | Samples will be analyzed for hemoglobin (Hb) concentration, mean corpuscular volume (MCV), hematocrit (HCT), reticulocytes (RET) concentration, serum ferritin, hepcidin, soluble transferrin receptor and calculated soluble transfferin receptor ratio (sTfR), reticulocyte hemoglobin. | 4, 12 and 24 months | |
Secondary | Growth | Weight, length and head circumference will be recorded at 4, 6, 9, 12, 24 and 36 months. | 4, 6, 9, 12, 24 and 36 months | |
Secondary | Behaviour | Behaviour will be assessed with use of child behavioral checklist (CBCL) | 36 months | |
Secondary | Adverse events | Parents will be asked to fill out a form of possible adverse events of the intervention daily. The symptoms listed in the form will include diarrhoea, vomiting, constipation, discolouration of the stool, fever, and respiratory tract infections. The forms will be collected at each check-up visit during the intervention. | untill 9 months of age (during intervention) |
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