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

The Hospital for Sick Children

Status: Completed

Conditions: Non-anemic Iron Deficiency

Treatments: Behavioral: Dietary counseling; Dietary Supplement: Ferrous Sulfate; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01481766

1000027782

Details and patient eligibility

About

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.

Enrollment: 127 patients

Sex: All

Ages: 12 to 40 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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127 participants in 4 patient groups, including a placebo group

Iron plus dietary counseling (Non-anemic iron deficiency)

Experimental group

Treatment:

Dietary Supplement: Ferrous Sulfate

Behavioral: Dietary counseling

Placebo plus dietary counseling (Non-anemic iron deficiency)

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo

Behavioral: Dietary counseling

Iron sufficient

No Intervention group

Description:

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.

Iron deficiency anemia

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Ferrous Sulfate

Behavioral: Dietary counseling