Iron Supplement Effect on Child Development

Study Overview
=================
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.

Official Title
-----------------
Iron Supplement Effect Over Immune System and Neurobehavioral Child Development.

Conditions
-----------------
Neurodevelopmental Disorders, Lactation

Intervention / Treatment
-----------------
* Dietary Supplement: Iron fortified formula milk


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Maximum Age: 6 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention high-iron fortified milk<br>This group received a high dose of iron by formula milk (1.2mg/100mL) between 6 and 12 months of age. | Dietary Supplement: Iron fortified formula milk<br>* 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.<br>|
| Experimental: Intervention low-iron fortified milk<br>This group received a low dose of iron by formula milk (0.4mg/100mL) between 6 and 12 months of age. | Dietary Supplement: Iron fortified formula milk<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mental and psychomotor development with BSID (Bayley Scale of Infant Development) at 12 months. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Risk of infections at 12 months measured qualitatively from record of presence or not of various infections as bronchitis, rhinitis, otitis etc. |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neurodevelopment, Bayley Scale, Growth, Iron fortification