Iron Treatment for Young Children With Non-anemic Iron Deficiency (OptEC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by The Hospital for Sick Children
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Mead Johnson Nutrition
Mount Sinai Hospital, Canada
St. Michael's Hospital, Toronto
Information provided by (Responsible Party):
Patricia Parkin, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01481766
First received: November 22, 2011
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Non-anemic Iron Deficiency
Dietary Supplement: Ferrous Sulfate
Dietary Supplement: Placebo
Behavioral: Dietary counseling
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Mullen Scales of Early Learning [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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:
  • Laboratory measures [ Time Frame: Baseline and 4 months post-treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 230
Study Start Date: June 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Iron plus dietary counseling (Non-anemic iron deficiency) 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
Other Names:
  • Brand name: Fer-In-Sol by Mead Johnson Nutrition
  • NPN #: 00762954
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.
Placebo Comparator: Placebo plus dietary counseling (Non-anemic iron deficiency) Dietary Supplement: 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.
No Intervention: 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.
Active Comparator: 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.
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
Other Names:
  • Brand name: Fer-In-Sol by Mead Johnson Nutrition
  • NPN #: 00762954
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.

  Eligibility

Ages Eligible for Study:   18 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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, 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01481766

Contacts
Contact: Patricia C Parkin, MD 416-813-6933 patricia.parkin@sickkids.ca
Contact: Jonathon Maguire, MD, MSc 416-919-3462 jonathon.maguire@utoronto.ca

Locations
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Patricia Parkin, MD    416-813-6933    patricia.parkin@sickkids.ca   
Principal Investigator: Patricia Parkin, MD         
Sub-Investigator: Catherine S Birken, MD, MSc         
Sub-Investigator: Colin Macarthur, MBBS, PhD         
Sub-Investigator: Stanley Zlotkin, MD, PhD         
Sub-Investigator: Muhammad Mamdani, PharmD, MPH         
Sub-Investigator: Kevin Thorpe, MSc         
Sub-Investigator: Eva Mamak, PhD         
Sub-Investigator: Kawsari Abdullah, MBBS         
Sub-Investigator: Darcy Fehlings, MD         
Sub-Investigator: Jonathon Maguire, MD, MSc         
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Jonathon Maguire, MD, MSc    416-919-3462    jonathon.maguire@utoronto.ca   
Principal Investigator: Jonathon Maguire, MD, MSc         
Sub-Investigator: Patricia Parkin, MD         
Sub-Investigator: Catherine Birken, MD, MSc         
Sub-Investigator: Colin Macarthur, MBBS, PhD         
Sub-Investigator: Eva Mamak, PhD         
Sub-Investigator: Stanley Zlotkin, MD, PhD         
Sub-Investigator: Muhammad Mamdani, PharmD, MPH         
Sub-Investigator: Kevin Thorpe, MSc         
Sub-Investigator: Kawsari Abdullah, MBBS         
Sub-Investigator: Darcy Fehlings, MD         
Sponsors and Collaborators
The Hospital for Sick Children
Canadian Institutes of Health Research (CIHR)
Mead Johnson Nutrition
Mount Sinai Hospital, Canada
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: Parkin C Parkin, MD The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Patricia Parkin, Staff Paediatrician, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01481766     History of Changes
Other Study ID Numbers: 1000027782
Study First Received: November 22, 2011
Last Updated: December 2, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
child development
screening
Non-anemic iron deficiency
primary care pediatrics
prevention and health promotion

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Iron Metabolism Disorders
Anemia, Hypochromic
Anemia
Hematologic Diseases
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014