Iron Treatment for Young Children With Non-anemic Iron Deficiency

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-anemic Iron Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The research pharmacy prepared ferrous sulfate and placebo in bottles of similar appearance and weight. The placebo was developed by the research pharmacy, was similar in color and consistency to the active agent, and had a distinctive taste.

Individuals masked to group allocation throughout the study included parents, attending physicians, research assistants, study personnel conducting outcome assessments, data analysts, and investigators. The biostatistician was unmasked after completion of data collection and locking of the database. The principal investigator was unmasked after the analysis.

Study Groups

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Iron plus dietary counseling (Non-anemic iron deficiency)

Group Type EXPERIMENTAL

Ferrous Sulfate

Intervention Type DIETARY_SUPPLEMENT

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

Dietary counseling

Intervention Type BEHAVIORAL

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 plus dietary counseling (Non-anemic iron deficiency)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

0.4 ml/kg/day in 2 or 3 divided doses (at the discretion of prescribing study doctor) for four months plus dietary counseling

Dietary counseling

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Ferrous Sulfate

Intervention Type DIETARY_SUPPLEMENT

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

Dietary counseling

Intervention Type BEHAVIORAL

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.

Interventions

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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

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Brand name: Fer-In-Sol by Mead Johnson Nutrition NPN #: 00762954

Eligibility Criteria

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Inclusion Criteria

* Age between 12 and 40 months attending any well child visit
* Informed parental consent

Exclusion Criteria

* developmental disorder
* genetic, chromosomal or syndromic condition
* chronic medical condition (with the exception of asthma and allergies)
* 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
* English is not spoken to the child in the home or in a child care setting
* CRP level ≥10 mg/L

Minimum Eligible Age

12 Months

Maximum Eligible Age

40 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes