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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).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention high-iron fortified milk | Experimental | This group received a high dose of iron by formula milk (1.2mg/100mL) between 6 and 12 months of age. |
|
| Intervention low-iron fortified milk | Experimental | This group received a low dose of iron by formula milk (0.4mg/100mL) between 6 and 12 months of age. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron fortified formula milk | Dietary Supplement | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mental and psychomotor development with BSID (Bayley Scale of Infant Development) at 12 months. | 12 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victoria Arija Val, Professor | University Rovira i Virgili | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31488098 | Derived | 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. |
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The investigators plan to share data in a submitted article in 2016
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| ID | Term |
|---|---|
| D065886 | Neurodevelopmental Disorders |
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| 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 |