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Iron Supplement Effect on Child Development

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02690675
First Posted: February 24, 2016
Last Update Posted: February 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Victoria Arija Val, University Rovira i Virgili
  Purpose

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).


Condition Intervention
Neurodevelopmental Disorders Lactation Dietary Supplement: Iron fortified formula milk

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Iron Supplement Effect Over Immune System and Neurobehavioral Child Development.

Resource links provided by NLM:


Further study details as provided by Victoria Arija Val, University Rovira i Virgili:

Primary Outcome Measures:
  • Mental and psychomotor development with BSID (Bayley Scale of Infant Development) at 12 months. [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Height at 12 months measured in centimeters [ Time Frame: 12 months ]
  • Weight at 12 months measured in grams [ Time Frame: 12 months ]
  • Head circumference at 12 months measured in centimeters [ Time Frame: 12 months ]
  • 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 ]

Enrollment: 133
Study Start Date: May 2006
Study Completion Date: December 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02690675


Sponsors and Collaborators
University Rovira i Virgili
Investigators
Principal Investigator: Victoria Arija Val, Professor Universitat Rovira i Virgili
  More Information

Responsible Party: Victoria Arija Val, University Professor, University Rovira i Virgili
ClinicalTrials.gov Identifier: NCT02690675     History of Changes
Other Study ID Numbers: EC81/00128
First Submitted: February 11, 2016
First Posted: February 24, 2016
Last Update Posted: February 25, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The investigators plan to share data in a submitted article in 2016

Keywords provided by Victoria Arija Val, University Rovira i Virgili:
Neurodevelopment
Bayley Scale
Growth
Iron fortification

Additional relevant MeSH terms:
Neurodevelopmental Disorders
Mental Disorders
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs


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