Clinical trial NCT01481766: Iron Treatment for Young Children With Non-anemic Iron Deficiency
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non-anemic Iron Deficiency
Keywords: child development
screening
Non-anemic iron deficiency
primary care pediatrics
prevention and health promotion
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Mead Johnson Nutrition
name: Mount Sinai Hospital, Canada
name: Unity Health Toronto
First posted: 2011-11-30
Enrollment: 132
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mullen Scales of Early Learning
timeFrame: Baseline
measure: Mullen Scales of Early Learning
timeFrame: 4 months and 12 months post-treatment
Secondary outcomes:
measure: Laboratory measures
timeFrame: Baseline and 4 months post-treatment
measure: Child temperament
timeFrame: Baseline and 4 months post-treatment
measure: Child growth
timeFrame: Baseline and 4 and 12 months post-treatment
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Parkin C Parkin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parkin PC, Borkhoff CM, Macarthur C, Abdullah K, Birken CS, Fehlings D, Koroshegyi C, Maguire JL, Mamak E, Mamdani M, Thorpe KE, Zlotkin SH, Zuo F; TARGet Kids! Collaboration. Randomized Trial of Oral Iron and Diet Advice versus Diet Advice Alone in Young Children with Nonanemic Iron Deficiency. J Pediatr. 2021 Jun;233:233-240.e1. doi: 10.1016/j.jpeds.2021.01.073. Epub 2021 Feb 4.
citation: Parkin PC, Koroshegyi C, Mamak E, Borkhoff CM, Birken CS, Maguire JL, Thorpe KE; TARGet Kids! Collaboration. Association between Serum Ferritin and Cognitive Function in Early Childhood. J Pediatr. 2020 Feb;217:189-191.e2. doi: 10.1016/j.jpeds.2019.09.051. Epub 2019 Nov 2.
citation: Abdullah K, Thorpe KE, Mamak E, Maguire JL, Birken CS, Fehlings D, Hanley AJ, Macarthur C, Zlotkin SH, Parkin PC. An internal pilot study for a randomized trial aimed at evaluating the effectiveness of iron interventions in children with non-anemic iron deficiency: the OptEC trial. Trials. 2015 Jul 14;16:303. doi: 10.1186/s13063-015-0829-4.
citation: Abdullah K, Thorpe KE, Mamak E, Maguire JL, Birken CS, Fehlings D, Hanley AJ, Macarthur C, Zlotkin SH, Parkin PC. Optimizing early child development for young children with non-anemic iron deficiency in the primary care practice setting (OptEC): study protocol for a randomized controlled trial. Trials. 2015 Apr 2;16:132. doi: 10.1186/s13063-015-0635-z.