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OpenTrials
Completed

NCT Number: NCT02690675

Iron Supplement Effect on 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).

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Key information

Conditions

Neurodevelopmental Disorders Behavior Breast Feeding Feeding Behavior Lactation Mental Disorders

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iron fortified formula milk

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.

Primary outcomes

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

    Time frame: 12 months

Secondary outcomes

  1. Height at 12 months measured in centimeters

    Time frame: 12 months

  2. Weight at 12 months measured in grams

    Time frame: 12 months

  3. Head circumference at 12 months measured in centimeters

    Time frame: 12 months

  4. 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

Sponsors and collaborators

Lead sponsor

University Rovira i Virgili

Other

Registry information

Official study title

Iron Supplement Effect Over Immune System and Neurobehavioral Child Development.

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Feb 24, 2016
Registry last updated
Feb 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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