Iron Treatment for Young Children With Non-anemic Iron Deficiency

Non-anemic Iron Deficiency Clinical Trial

— OptEC  

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 (OptEC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01481766
• Other study ID #: 1000027782
• Status: Completed
• Phase: Phase 4
• Start date: June 2012
• Est. completion date: December 2018

Study information

• Verified date: April 2019
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: December 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 40 Months

Eligibility

Inclusion Criteria:

• Age between 18 and 36 months attending any well child visit

• Informed parental consent

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Non-anemic Iron Deficiency

Intervention

Dietary Supplement:
• Ferrous Sulfate
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
• Placebo
0.4 ml/kg/day in 2 or 3 divided doses (at the discretion of prescribing study doctor) for four months plus dietary counseling

Behavioral:
• Dietary counseling
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.

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (5)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Canadian Institutes of Health Research (CIHR), Mead Johnson Nutrition, Mount Sinai Hospital, Canada, St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mullen Scales of Early Learning	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.	Baseline
Primary	Mullen Scales of Early Learning	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.	4 months and 12 months post-treatment
Secondary	Laboratory measures	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.	Baseline and 4 months post-treatment
Secondary	Child temperament	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.	Baseline and 4 months post-treatment
Secondary	Child growth	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.	Baseline and 4 and 12 months post-treatment