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Iron Supplement Effect on Child Development

Primary Purpose

Neurodevelopmental Disorders, Lactation

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Iron fortified formula milk

About this trial

This is an interventional prevention trial for Neurodevelopmental Disorders focused on measuring Neurodevelopment, Bayley Scale, Growth, Iron fortification

Eligibility Criteria

undefined - 6 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Intervention high-iron fortified milk

Intervention low-iron fortified milk

Arm Description

This group received a high dose of iron by formula milk (1.2mg/100mL) between 6 and 12 months of age.

This group received a low dose of iron by formula milk (0.4mg/100mL) between 6 and 12 months of age.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Height at 12 months measured in centimeters

Weight at 12 months measured in grams

Head circumference at 12 months measured in centimeters

Risk of infections at 12 months measured qualitatively from record of presence or not of various infections as bronchitis, rhinitis, otitis etc.

Full Information

NCT ID

NCT02690675

First Posted

February 11, 2016

Last Updated

February 24, 2016

Sponsor

University Rovira i Virgili

1. Study Identification

Unique Protocol Identification Number

NCT02690675

Brief Title

Iron Supplement Effect on Child Development

Official Title

Iron Supplement Effect Over Immune System and Neurobehavioral Child Development.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Completed

Study Start Date

May 2006 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Rovira i Virgili

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neurodevelopmental Disorders, Lactation

Keywords

Neurodevelopment, Bayley Scale, Growth, Iron fortification

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

133 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention high-iron fortified milk

Arm Type

Experimental

Arm Description

This group received a high dose of iron by formula milk (1.2mg/100mL) between 6 and 12 months of age.

Arm Title

Intervention low-iron fortified milk

Arm Type

Experimental

Arm Description

This group received a low dose of iron by formula milk (0.4mg/100mL) between 6 and 12 months of age.

Intervention Type

Dietary Supplement

Intervention Name(s)

Iron fortified formula milk

Intervention 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.

Primary Outcome Measure Information:

Title

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Height at 12 months measured in centimeters

Time Frame

12 months

Title

Weight at 12 months measured in grams

Time Frame

12 months

Title

Head circumference at 12 months measured in centimeters

Time Frame

12 months

Title

Risk of infections at 12 months measured qualitatively from record of presence or not of various infections as bronchitis, rhinitis, otitis etc.

Time Frame

12 months

10. Eligibility

Sex

All

Maximum Age & Unit of Time

6 Months

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Victoria Arija Val, Professor

Organizational Affiliation

University Rovira i Virgili

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The investigators plan to share data in a submitted article in 2016

Citations:

PubMed Identifier

31488098

Citation

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.

Results Reference

derived

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Iron Supplement Effect on Child Development

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