Iron Supplement Effect on Child Development

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).

Study Overview

• Status: Completed
• Conditions: Neurodevelopmental Disorders; Lactation
• Intervention / Treatment: Dietary supplement: Iron fortified formula milk

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 Type: Interventional
• Enrollment (Actual): 133
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention high-iron fortified milk; This group received a high dose of iron by formula milk (1.2mg/100mL) between 6 and 12 months of age.	Dietary supplement: Iron 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.
Experimental: Intervention low-iron fortified milk; This group received a low dose of iron by formula milk (0.4mg/100mL) between 6 and 12 months of age.	Dietary supplement: Iron 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Rovira i Virgili
• Investigators: Principal Investigator: Victoria Arija Val, Professor, University Rovira i Virgili

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: February 11, 2016
• First Submitted That Met QC Criteria: February 19, 2016
• First Posted (Estimate): February 24, 2016

Study Record Updates

• Last Update Posted (Estimate): February 25, 2016
• Last Update Submitted That Met QC Criteria: February 24, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Growth; Neurodevelopment; Iron fortification; Bayley Scale
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders
• Other Study ID Numbers: EC81/00128

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The investigators plan to share data in a submitted article in 2016