Iron Supplement Effect on Child Development

Neurodevelopmental Disorders Clinical Trial

Official title:

Iron Supplement Effect Over Immune System and Neurobehavioral Child Development.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02690675
• Other study ID #: EC81/00128
• Status: Completed
• Phase: N/A
• First received: February 11, 2016
• Last updated: February 24, 2016
• Start date: May 2006
• Est. completion date: December 2009

Study information

• Verified date: February 2016
• Source: University Rovira i Virgili
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: December 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Lactation
• Mental Disorders Diagnosed in Childhood
• Neurodevelopmental Disorders

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Rovira i Virgili

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mental and psychomotor development with BSID (Bayley Scale of Infant Development) at 12 months.		12 months	Yes
Secondary	Height at 12 months measured in centimeters		12 months	Yes
Secondary	Weight at 12 months measured in grams		12 months	Yes
Secondary	Head circumference at 12 months measured in centimeters		12 months	Yes
Secondary	Risk of infections at 12 months measured qualitatively from record of presence or not of various infections as bronchitis, rhinitis, otitis etc.		12 months	Yes