Iron Supplement Effect Over Immune System and Neurobehavioral Child Development.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 133
- Primary Endpoint
- Mental and psychomotor development with BSID (Bayley Scale of Infant Development) at 12 months.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- — to 6 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Mental and psychomotor development with BSID (Bayley Scale of Infant Development) at 12 months.
Time Frame: 12 months
Secondary Outcomes
- 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)
Investigators
Victoria Arija Val
University Professor
University Rovira i Virgili