N/A Completed N=251 Randomized Quadruple-blind Prevention

Nutritional Education and the Prevention of Iron Depletion in Children 9 Months to 2 Years

Iron Deficiency

Source: ClinicalTrials.gov NCT00907088 ↗

Enrolled (actual)

251

Serious AEs

0.0%

Results posted

Apr 2014

Primary outcomePrimary: The Primary Outcome is Iron Depletion, and Will be Defined as Serum Ferritin <10 mcg/L. — 64; 71; 13; 10 participants — p=0.42

Summary

Iron depletion in young children is common and may progress to iron deficiency anemia which is associated with irreversible neurodevelopmental effects. Efforts to prevent iron depletion are key to preventing these effects. In a recent study of 150 young children (12 to 38 months), we found that bottle fed children were almost three times as likely to be iron depleted compared with cup fed children (37% vs 18%). Thus, we hypothesize that an educational intervention designed to encourage timely bottle weaning will lead to a reduction in iron depletion.

Outcome Measures

Outcome	Result	p-value
PRIMARY The Primary Outcome is Iron Depletion, and Will be Defined as Serum Ferritin <10 mcg/L.	64; 71; 13; 10; 22; 21	0.42
SECONDARY Iron Deficiency (Defined as Serum Ferritin <10 mcg/L and MCV < 70 mcm3 Iron Deficiency.	—	—
SECONDARY IDA (Hemoglobin < 110 g/L With Iron Deficiency)	—	—

Eligibility Criteria

Inclusion Criteria

Children aged 9 months who are attending a routine primary care well-child visit.
Children who are in good general health.
Children whose parents provide informed consent to participate.

Exclusion Criteria

Children with chronic illness.
Children with birth weight less than 2.5 kg.
Children with previously diagnosed anemia (including known iron deficiency anemia). This includes children with marrow failure (aplastic anemia, Fanconi anemia), hemoglobinopathies (sickle cell disease, thalassemia), lead intoxication, sideroblastic anemia, megaloblastic anemia, enzymopathies (G6PD deficiency, pyruvate kinase deficiency), or membranopathies (hereditary spherocytosis).
Children currently receiving medications associated with anemia. This includes children taking antimetabolites or phenytoin.
Children currently receiving iron supplementation other than iron fortified formula.

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Data sourced from ClinicalTrials.gov (NCT00907088). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.