Iron Supplement Effect on Child Development

NCT ID: NCT02690675

Last Updated: 2016-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2009-12-31

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.

Conditions

Neurodevelopmental Disorders; Lactation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Iron fortified formula milk

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Iron fortified formula milk

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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

• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Rovira i Virgili

OTHER

Sponsor Role: lead

Responsible Party

Victoria Arija Val

University Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Victoria Arija Val, Professor

Role: PRINCIPAL_INVESTIGATOR

University Rovira i Virgili

References

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.

Reference Type: DERIVED

PMID: 31488098 (View on PubMed)

Other Identifiers

EC81/00128

Identifier Type: -

Identifier Source: org_study_id