Clinical trial NCT02690675: Iron Supplement Effect on Child Development
Official title: Iron Supplement Effect Over Immune System and Neurobehavioral Child Development.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurodevelopmental Disorders
Lactation
Keywords: Neurodevelopment
Bayley Scale
Growth
Iron fortification
Lead sponsor: University Rovira i Virgili
Sponsor class: OTHER
First posted: 2016-02-24
Enrollment: 133
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Mental and psychomotor development with BSID (Bayley Scale of Infant Development) at 12 months.
timeFrame: 12 months
Secondary outcomes:
measure: Height at 12 months measured in centimeters
timeFrame: 12 months
measure: Weight at 12 months measured in grams
timeFrame: 12 months
measure: Head circumference at 12 months measured in centimeters
timeFrame: 12 months
measure: Risk of infections at 12 months measured qualitatively from record of presence or not of various infections as bronchitis, rhinitis, otitis etc.
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: University Rovira i Virgili
name: Victoria Arija Val, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Iglesias Vazquez L, Canals J, Voltas N, Jardi C, Hernandez C, Bedmar C, Escribano J, Aranda N, Jimenez R, Barroso JM, Ribot B, Arija V. Does the fortified milk with high iron dose improve the neurodevelopment of healthy infants? Randomized controlled trial. BMC Pediatr. 2019 Sep 5;19(1):315. doi: 10.1186/s12887-019-1679-0.