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Completed

NCT Number: NCT01481766

Iron Treatment for Young Children With Non-anemic Iron Deficiency

The pre-school years are critical years for children to acquire early learning skills such as language, fine motor and social skills; this is termed early child development. Primary care doctors (family doctors and pediatricians) are in a unique position to identify children with health or developmental problems. Screening is the process of testing healthy people for the earliest signs of health problems, followed by treatment, with the expectation that screening will improve the health of those screened. The focus of this research is screening young children for the earliest signs of iron deficiency (low blood iron levels) followed by treatment with oral iron.

Previous research has shown that children with later stages of iron deficiency have serious delays in their development. Some research has shown that these delays may persist into young adulthood often with a significant reduction in intelligence. Early stages of iron deficiency may be difficult for parents or doctors to detect, and a blood test is usually needed. However, Canadian guidelines do not recommend screening all children for iron deficiency, because there is not enough good quality research to prove that screening is effective.

In this study, the investigators will ask parents to allow their child between the ages of 1 to 3 years to have a blood test for iron levels. If the blood level is low, the child will be randomly assigned to receive either oral iron liquid for 4 months plus diet counseling, or a placebo liquid plus diet counseling. A psychologist will measure each child's early learning ability before and after the treatment. If this approach to screening children's blood iron levels followed by treatment improves children's development, parents and doctors may consider that routine blood screening tests are justified. Overall, this research is an important step to improving the ways in which primary care doctors can ensure that children have the best start to life-long health and achievement.

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Key information

Conditions

Non-anemic Iron Deficiency Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

12 month–40 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Michael's Hospital, Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age between 12 and 40 months attending any well child visit
  • Informed parental consent

Exclusion criteria

  • developmental disorder
  • genetic, chromosomal or syndromic condition
  • chronic medical condition (with the exception of asthma and allergies)
  • chronic anemia, iron deficiency, or recent oral iron supplementation or treatment
  • prematurity, with a gestational age of less than 35 weeks
  • low birth weight less than 2,500 g;
  • attending the office for an acute illness, such as a viral illness, or other health concern other than for a well-child assessment
  • any contraindications to receiving elemental iron
  • the use of any natural health product containing the same medicinal ingredient(s) as the investigational product
  • English is not spoken to the child in the home or in a child care setting
  • CRP level ≥10 mg/L

Treatment and study plan

Ferrous Sulfate

Dietary Supplement

6 mg elemental iron/kg/day (0.4 ml/kg/day) in 2 or 3 divided doses (at the discretion of prescribing study doctor) for four months plus dietary counseling

Other names: Brand name: Fer-In-Sol by Mead Johnson Nutrition, NPN #: 00762954

Placebo

Dietary Supplement

0.4 ml/kg/day in 2 or 3 divided doses (at the discretion of prescribing study doctor) for four months plus dietary counseling

Dietary Counseling

Behavioral

Dietary counseling will include written recommendations regarding maximum daily cow's milk intake, varied solid food intake including high iron containing foods, and avoidance of foods which reduce iron absorption.

Primary outcomes

  1. Early Learning Composite (ELC) From the Mullen Scales of Early Learning

    Time frame: Baseline and 4 months after enrollment

    ELC is a measure of infant cognition (similar to IQ). In populations, infants have a mean score of 100 points and standard deviation of 15 points. A higher score indicates higher cognitive ability. Four cognitive skills are summarized into an Early Learning Composite score - Fine Motor, Visual Reception, Receptive Language, and Expressive Language.

Secondary outcomes

  1. Serum Ferritin

    Time frame: 4 months after enrollment

    Blood samples analyzed for serum ferritin

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Mead Johnson Nutrition
  • Mount Sinai Hospital, Canada
  • Unity Health Toronto

Registry information

Official study title

Optimizing Early Child Development in the Primary Care Practice Setting: Pragmatic Randomized Trial of Iron Treatment for Young Children With Non-anemic Iron Deficiency (OptEC)

Acronym: OptEC

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Nov 30, 2011
Registry last updated
Oct 30, 2025

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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