Iron Treatment for Young Children With Non-anemic Iron Deficiency
- Conditions
- Non-anemic Iron Deficiency
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: Ferrous SulfateBehavioral: Dietary counseling
- Registration Number
- NCT01481766
- Lead Sponsor
- The Hospital for Sick Children
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 132
- Age between 18 and 36 months attending any well child visit
- Informed parental consent
- Previously diagnosed: developmental disorder, genetic, chromosomal or syndromic condition, chronic medical condition, (with the exception of asthma and allergies), including chronic anemia, iron deficiency or recent oral iron supplementation or treatment
- Prematurity with a gestational age less than 35 weeks; low birth weight less than 2500 grams
- Attending the office for an acute illness, such as a viral illness, or other health concern other than well-child assessment
- Any contraindications to receiving elemental iron (i.e. NHP [natural health product], comparator or placebo)
- The use of any Natural Health Product containing the same medicinal ingredient(s) as the investigational product
- English not spoken to the child in the home or in a child care setting
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo plus dietary counseling (Non-anemic iron deficiency) Placebo - Iron deficiency anemia Ferrous Sulfate 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) Ferrous Sulfate - Placebo plus dietary counseling (Non-anemic iron deficiency) Dietary counseling - Iron deficiency anemia Dietary counseling 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) Dietary counseling -
- Primary Outcome Measures
Name Time Method Mullen Scales of Early Learning 4 months and 12 months post-treatment The Mullen Scales of Early Learning assess the cognitive functioning of young children from birth to 68 months. The assessment is based on the child's responses to activities prepared by the trained examiner. Five skill areas are measured: Gross Motor and four cognitive skills (summarized into an Early Learning Composite score) - Fine Motor, Visual Reception, Receptive Language, and Expressive Language. The raw scores for each scale can be converted into age-adjusted normalized scores.
- Secondary Outcome Measures
Name Time Method Laboratory measures Baseline and 4 months post-treatment The current study focuses on laboratory measures of iron status, including hemoglobin, mean corpuscular volume, and serum ferritin. Standardized reference ranges will be used to determine if the result is normal or abnormal.
Child temperament Baseline and 4 months post-treatment The Early Childhood Behavior Questionnaire (ECBQ) assesses the following dimensions in children 18-36 months: Activity level/Energy, Attentional Focusing, Attentional Shifting, Cuddliness, Discomfort, Fear, Frustration, High-intensity Pleasure, Impulsivity, Inhibitory Control, Low-intensity Pleasure, Motor Activation, Perceptual Sensitivity, Positive Anticipation, Sadness, Shyness, Sociability, Soothability.
Child growth Baseline and 4 and 12 months post-treatment Growth will be measured as children's weight and height/length and then converted to age and sex adjusted z-scores using the WHO growth standards. Growth indicators will include - z-scores for weight for height (WHZ), weight for age (WAZ), height for age (HAZ) and BMI for age (BMI-AZ). BMI will be calculated as weight in kilograms divided by height in meters squared.
Trial Locations
- Locations (2)
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada