Clinical Trial: Iron Treatment for Young Children With Non-anemic Iron Deficiency

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official 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 (O

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

Detailed Summary:
Sponsor: The Hospital for Sick Children

Current Primary Outcome:

• Mullen Scales of Early Learning [ Time Frame: Baseline ]
  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.
• Mullen Scales of Early Learning [ Time Frame: 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.

Original Primary Outcome:

• Mullen Scales of Early Learning [ Time Frame: Baseline ]
  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.
• Mullen Scales of Early Learning [ Time Frame: 4 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.

Current Secondary Outcome:

• Laboratory measures [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

Original Secondary Outcome:

• Laboratory measures [ Time Frame: 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 [ Time Frame: 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.

Dates:
Date Received: November 22, 2011
Date Started: June 2012
Date Completion: December 2018
Last Updated: May 2, 2017
Last Verified: May 2017