Iron Supplement Effect on Child Development

Not Applicable

Completed

• Conditions: Neurodevelopmental Disorders; Lactation
• Interventions: Dietary Supplement: Iron fortified formula milk

• Registration Number: NCT02690675
• Lead Sponsor: University Rovira i Virgili

Brief 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.

Study Timeline

• Study Start: 2006-05
• Primary Completion: 2009-06
• Study Completion: 2009-12
• Status Verified: 2016-02
• Study First Submitted: 2016-02-11
• Study First Submitted QC: 2016-02-19
• Study First Posted: 2016-02-24
• Last Update Submitted: 2016-02-24
• Last Update Posted: 2016-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention low-iron fortified milk	Iron fortified formula milk	This group received a low dose of iron by formula milk (0.4mg/100mL) between 6 and 12 months of age.
Intervention high-iron fortified milk	Iron fortified formula milk	This group received a high dose of iron by formula milk (1.2mg/100mL) between 6 and 12 months of age.

Primary Outcome Measures

Name	Time	Method
Mental and psychomotor development with BSID (Bayley Scale of Infant Development) at 12 months.	12 months

Secondary Outcome Measures

Name	Time	Method
Risk of infections at 12 months measured qualitatively from record of presence or not of various infections as bronchitis, rhinitis, otitis etc.	12 months
Height at 12 months measured in centimeters	12 months
Weight at 12 months measured in grams	12 months
Head circumference at 12 months measured in centimeters	12 months