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Iron Supplement Effect on Child Development

Iron Supplement Effect Over Immune System and Neurobehavioral Child Development.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02690675
Enrollment
133
Registered
2016-02-24
Start date
2006-05-31
Completion date
2009-12-31
Last updated
2016-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lactation, Neurodevelopmental Disorders

Keywords

Neurodevelopment, Bayley Scale, Growth, Iron fortification

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.

Interventions

DIETARY_SUPPLEMENTIron 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.

Sponsors

University Rovira i Virgili
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
No minimum to 6 Months
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

Design outcomes

Primary

MeasureTime frame
Mental and psychomotor development with BSID (Bayley Scale of Infant Development) at 12 months.12 months

Secondary

MeasureTime frame
Height at 12 months measured in centimeters12 months
Weight at 12 months measured in grams12 months
Head circumference at 12 months measured in centimeters12 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026