Non-anemic Iron Deficiency Clinical Trial
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)
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02683369 -
Low-dose Iron Supplementation and Markers of Iron Status Among Non-anemic, Iron-deficient Women
|
Phase 2/Phase 3 | |
| Recruiting |
NCT05423249 -
Treatment of Non-Anemic Iron Deficiency in Pregnancy
|
N/A |