Iron Supplement Effect on Child Development

University Rovira i Virgili

Status: Completed

Conditions: Neurodevelopmental Disorders; Lactation

Treatments: Dietary Supplement: Iron fortified formula milk

Study type: Interventional

Funder types: Other

Identifiers

NCT02690675

EC81/00128

Details and patient eligibility

About

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).

Full 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.

Enrollment: 133 patients

Sex: All

Ages: Under 6 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Caucasian infants
• Healthy term infants

Exclusion criteria

• Families that do not understand Spanish or Catalan
• Anaemic infants at birth
• Infants with important diseases

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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133 participants in 2 patient groups

Intervention high-iron fortified milk

Experimental group

Description:

This group received a high dose of iron by formula milk (1.2mg/100mL) between 6 and 12 months of age.

Treatment:

Dietary Supplement: Iron fortified formula milk

Intervention low-iron fortified milk

Experimental group

Description:

This group received a low dose of iron by formula milk (0.4mg/100mL) between 6 and 12 months of age.

Treatment:

Dietary Supplement: Iron fortified formula milk