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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.

Abdullah K, Thorpe KE, Mamak E, Maguire JL, Birken CS, Fehlings D, Hanley AJ, Macarthur C, Zlotkin SH, Parkin PC - Trials (2015)

Bottom Line: There is little research regarding NAID, which may be associated with delayed development in young children.The aim of this study is to compare the effectiveness of four months of oral iron treatment plus dietary advice, with placebo plus dietary advice, in improving developmental outcomes in children with NAID and to conduct an internal pilot study.Change in developmental and laboratory measures from baseline to the end of the four-month follow-up period will be analyzed using linear regression (analysis of covariance method).

View Article: PubMed Central - PubMed

Affiliation: Pediatric Outcomes Research Team, Division of Pediatric Medicine, Department of Pediatrics, The Hospital for Sick Children, 555 University Avenue, M5G 1X8, Toronto, Canada. kawsari.abdullah@sickkids.ca.

ABSTRACT

Background: Three decades of research suggests that prevention of iron deficiency anemia (IDA) in the primary care setting may be an unrealized and unique opportunity to prevent poor developmental outcomes in children. A longitudinal study of infants with IDA showed that the developmental disadvantage persists long term despite iron therapy. Early stages of iron deficiency, termed non-anemic iron deficiency (NAID), provide an opportunity for early detection and treatment before progression to IDA. There is little research regarding NAID, which may be associated with delayed development in young children. The aim of this study is to compare the effectiveness of four months of oral iron treatment plus dietary advice, with placebo plus dietary advice, in improving developmental outcomes in children with NAID and to conduct an internal pilot study.

Methods/design: From a screening cohort, those identified with NAID (hemoglobin ≥110 g/L and serum ferritin <14 μg/L) are invited to participate in a pragmatic, multi-site, placebo controlled, blinded, parallel group, superiority randomized trial. Participating physicians are part of a primary healthcare research network called TARGet Kids! Children between 12 and 40 months of age and identified with NAID are randomized to receive four months of oral iron treatment at 6 mg/kg/day plus dietary advice, or placebo plus dietary advice (75 per group). The primary outcome, child developmental score, is assessed using the Mullen Scales of Early Learning at baseline and at four months after randomization. Secondary outcomes include an age appropriate behavior measure (Children's Behavior Questionnaire) and two laboratory measures (hemoglobin and serum ferritin levels). Change in developmental and laboratory measures from baseline to the end of the four-month follow-up period will be analyzed using linear regression (analysis of covariance method).

Discussion: This trial will provide evidence regarding the association between child development and NAID, and the effectiveness of oral iron to improve developmental outcomes in children with NAID. The sample size of the trial will be recalculated using estimates taken from an internal pilot study.

Trial registration: This trial was registered with Clinicaltrials.gov (identifier: NCT01481766 ) on 22 November 2011.

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Related in: MedlinePlus

Study schematic of the ‘Optimizing Early Child Development in the Primary Care Physician Practice Setting: Pragmatic Randomized Trial of Iron Treatment for Young Children with Non-Anemic Iron Deficiency’ (OptEC) trial. IBQ/ECBQ/CBQ: Infant Behavior Questionnaire/Early Childhood Behavior Questionnaire/Children’s Behavior Questionnaire.
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Fig1: Study schematic of the ‘Optimizing Early Child Development in the Primary Care Physician Practice Setting: Pragmatic Randomized Trial of Iron Treatment for Young Children with Non-Anemic Iron Deficiency’ (OptEC) trial. IBQ/ECBQ/CBQ: Infant Behavior Questionnaire/Early Childhood Behavior Questionnaire/Children’s Behavior Questionnaire.

Mentions: In this trial, only children diagnosed with NAID are randomized to the intervention and control groups. The other two groups (IDA and IS) are non-randomized comparators (Figure 1: schematic of study plan). However, for all three groups, we exclude children with any of the following: a CRP level ≥10 mg/L; a previously diagnosed developmental disorder; a 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 of less than 35 weeks; low birth weight less than 2,500 g; attending the office for an acute illness, such as a viral illness, or other health concern other than for a well-child assessment; any contraindications to receiving elemental iron; the use of any natural health product containing the same medicinal ingredient(s) as the investigational product; or if English is not spoken to the child in the home or in a child care setting.Figure 1


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.

Abdullah K, Thorpe KE, Mamak E, Maguire JL, Birken CS, Fehlings D, Hanley AJ, Macarthur C, Zlotkin SH, Parkin PC - Trials (2015)

Study schematic of the ‘Optimizing Early Child Development in the Primary Care Physician Practice Setting: Pragmatic Randomized Trial of Iron Treatment for Young Children with Non-Anemic Iron Deficiency’ (OptEC) trial. IBQ/ECBQ/CBQ: Infant Behavior Questionnaire/Early Childhood Behavior Questionnaire/Children’s Behavior Questionnaire.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4389731&req=5

Fig1: Study schematic of the ‘Optimizing Early Child Development in the Primary Care Physician Practice Setting: Pragmatic Randomized Trial of Iron Treatment for Young Children with Non-Anemic Iron Deficiency’ (OptEC) trial. IBQ/ECBQ/CBQ: Infant Behavior Questionnaire/Early Childhood Behavior Questionnaire/Children’s Behavior Questionnaire.
Mentions: In this trial, only children diagnosed with NAID are randomized to the intervention and control groups. The other two groups (IDA and IS) are non-randomized comparators (Figure 1: schematic of study plan). However, for all three groups, we exclude children with any of the following: a CRP level ≥10 mg/L; a previously diagnosed developmental disorder; a 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 of less than 35 weeks; low birth weight less than 2,500 g; attending the office for an acute illness, such as a viral illness, or other health concern other than for a well-child assessment; any contraindications to receiving elemental iron; the use of any natural health product containing the same medicinal ingredient(s) as the investigational product; or if English is not spoken to the child in the home or in a child care setting.Figure 1

Bottom Line: There is little research regarding NAID, which may be associated with delayed development in young children.The aim of this study is to compare the effectiveness of four months of oral iron treatment plus dietary advice, with placebo plus dietary advice, in improving developmental outcomes in children with NAID and to conduct an internal pilot study.Change in developmental and laboratory measures from baseline to the end of the four-month follow-up period will be analyzed using linear regression (analysis of covariance method).

View Article: PubMed Central - PubMed

Affiliation: Pediatric Outcomes Research Team, Division of Pediatric Medicine, Department of Pediatrics, The Hospital for Sick Children, 555 University Avenue, M5G 1X8, Toronto, Canada. kawsari.abdullah@sickkids.ca.

ABSTRACT

Background: Three decades of research suggests that prevention of iron deficiency anemia (IDA) in the primary care setting may be an unrealized and unique opportunity to prevent poor developmental outcomes in children. A longitudinal study of infants with IDA showed that the developmental disadvantage persists long term despite iron therapy. Early stages of iron deficiency, termed non-anemic iron deficiency (NAID), provide an opportunity for early detection and treatment before progression to IDA. There is little research regarding NAID, which may be associated with delayed development in young children. The aim of this study is to compare the effectiveness of four months of oral iron treatment plus dietary advice, with placebo plus dietary advice, in improving developmental outcomes in children with NAID and to conduct an internal pilot study.

Methods/design: From a screening cohort, those identified with NAID (hemoglobin ≥110 g/L and serum ferritin <14 μg/L) are invited to participate in a pragmatic, multi-site, placebo controlled, blinded, parallel group, superiority randomized trial. Participating physicians are part of a primary healthcare research network called TARGet Kids! Children between 12 and 40 months of age and identified with NAID are randomized to receive four months of oral iron treatment at 6 mg/kg/day plus dietary advice, or placebo plus dietary advice (75 per group). The primary outcome, child developmental score, is assessed using the Mullen Scales of Early Learning at baseline and at four months after randomization. Secondary outcomes include an age appropriate behavior measure (Children's Behavior Questionnaire) and two laboratory measures (hemoglobin and serum ferritin levels). Change in developmental and laboratory measures from baseline to the end of the four-month follow-up period will be analyzed using linear regression (analysis of covariance method).

Discussion: This trial will provide evidence regarding the association between child development and NAID, and the effectiveness of oral iron to improve developmental outcomes in children with NAID. The sample size of the trial will be recalculated using estimates taken from an internal pilot study.

Trial registration: This trial was registered with Clinicaltrials.gov (identifier: NCT01481766 ) on 22 November 2011.

Show MeSH
Related in: MedlinePlus