Iron Treatment for Young Children With Non-anemic Iron Deficiency
Condition: Non-anemic Iron Deficiency
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional
Phase: Phase 4

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.
    


Intervention name(s): Ferrous Sulfate; Placebo; Dietary counseling
Intervention type(s): Dietary Supplement; Dietary Supplement; Behavioral
Intervention description(s): 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; 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 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.
Other intervention name(s): Brand name: Fer-In-Sol by Mead Johnson Nutrition; NPN #: 00762954
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: child development; screening; Non-anemic iron deficiency; primary care pediatrics; prevention and health promotion