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Report for Clinical Trial NCT02690675

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Iron Supplement Effect Over Immune System and Neurobehavioral Child Development.

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).

NCT02690675 Neurodevelopmental Disorders Lactation
MeSH:Neurodevelopmental Disorders

1 Interventions

Name: Iron fortified formula milk

Description: 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.
Type: Dietary Supplement
Group Labels: 2

Intervention high-iron fortified milk Intervention low-iron fortified milk


Primary Outcomes

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

Time: 12 months

Secondary Outcomes

Measure: Height at 12 months measured in centimeters

Time: 12 months

Measure: Weight at 12 months measured in grams

Time: 12 months

Measure: Head circumference at 12 months measured in centimeters

Time: 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.

Time: 12 months

Purpose: Prevention

Allocation: Randomized

Parallel Assignment


There are 3 SNPs

SNPs


1 C282Y

Mutations in the HFE gene: C282Y, H63D, S65D and hepcidin gene. --- C282Y ---


2 H63D

Mutations in the HFE gene: C282Y, H63D, S65D and hepcidin gene. --- C282Y --- --- H63D ---


3 S65D

Mutations in the HFE gene: C282Y, H63D, S65D and hepcidin gene. --- C282Y --- --- H63D --- --- S65D ---



HPO Nodes