NCT02690675

Iron Supplement Effect on Child Development

Iron Supplement Effect Over Immune System and Neurobehavioral Child Development.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: University Rovira i Virgili · Academic / Other
• Sex: All
• Age: 6 Months
• Healthy volunteers: Accepted

Summary

Objective: To evaluate the effect of Iron supplement with two different amounts (one in the higher limit and another in the lower limit of the suggested amount) according to the presence of mutations in the HFE gene in the physical, immune and neurobehavioral development in the 6 to 12 moth toddlers. Methodology: Subjects: 340 toddlers coming from Paediatric Serves of Sant Joan Hospital. Methods: At 6 and 12 months it done clinical history, food registry, biochemist determinations: haemoglobin, iron, transferrin, ferritin, reactive C protein and immune response (IL4, IL10, IL6 IFN, IgA, IgM, IgG, IgE). Mutations in the HFE gene: C282Y, H63D, S65D and hepcidin gene. Mental, psychomotor and behavioual development (Bayley Scales of Infant Development 2on Edition: 1993). We evaluate the level of language and communication (MacArthur), regulation and sensory process (Infant Toddler Symptom Checklist), familiar and environment surroundings (Scale Health General Parental Stress Index).

Detailed description

Design: Randomised Clinical Trial with two groups of intervention. Group A received high-iron fortified milk (1.2mg/100mL) and Group B received low-iron fortified milk (0.4mg/100mL). Inclusion criteria: caucasian new-borns, term infants. Exclusion criteria: * Families that refuse enter at the follow-up. * Low-birth weight or preterm infants. * Anaemic infants. * Infants with congenital defects, immunodeficiency or hypothyroidism. * Infants with diseases that requires intensive care.

Conditions

• Neurodevelopmental Disorders
• Lactation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Iron fortified formula milk	One group received formula milk fortified with 1.2 mg/100 mL and the other group 0.4 mg/100mL between 6 and 12 months of age.

Timeline

• Start date: 2006-05-01
• Primary completion: 2009-06-01
• Completion: 2009-12-01
• First posted: 2016-02-24
• Last updated: 2016-02-25