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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 127
- Locations
- 4
- Primary Endpoint
- Early Learning Composite (ELC) From the Mullen Scales of Early Learning
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
The research pharmacy prepared ferrous sulfate and placebo in bottles of similar appearance and weight. The placebo was developed by the research pharmacy, was similar in color and consistency to the active agent, and had a distinctive taste.
Individuals masked to group allocation throughout the study included parents, attending physicians, research assistants, study personnel conducting outcome assessments, data analysts, and investigators. The biostatistician was unmasked after completion of data collection and locking of the database. The principal investigator was unmasked after the analysis.
Eligibility Criteria
- Ages
- 12 Months to 40 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Iron plus dietary counseling (Non-anemic iron deficiency)
Intervention: Dietary counseling (Behavioral)
Placebo plus dietary counseling (Non-anemic iron deficiency)
Intervention: Placebo (Dietary Supplement)
Placebo plus dietary counseling (Non-anemic iron deficiency)
Intervention: Dietary counseling (Behavioral)
Iron sufficient
From the screening cohort of it is anticipated that 25 children will have iron deficiency anemia and an equal number of randomly selected children with iron sufficiency (n=25) will be sampled. These children will be compared to the children with non-anemic iron deficiency.
Iron plus dietary counseling (Non-anemic iron deficiency)
Intervention: Ferrous Sulfate (Dietary Supplement)
Iron deficiency anemia
From the screening cohort of it is anticipated that 25 children will have iron deficiency anemia and an equal number of randomly selected children with iron sufficiency (n=25) will be sampled. These children will be compared to the children with non-anemic iron deficiency.
Intervention: Dietary counseling (Behavioral)
Iron deficiency anemia
From the screening cohort of it is anticipated that 25 children will have iron deficiency anemia and an equal number of randomly selected children with iron sufficiency (n=25) will be sampled. These children will be compared to the children with non-anemic iron deficiency.
Intervention: Ferrous Sulfate (Dietary Supplement)
Outcomes
Primary Outcomes
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
- Serum Ferritin(4 months after enrollment)