Iron Deficiency
Conditions
Keywords
Iron depletion, Children, Educational intervention, Office-based
Brief summary
Iron depletion in young children is common and may progress to iron deficiency anemia which is associated with irreversible neurodevelopmental effects. Efforts to prevent iron depletion are key to preventing these effects. In a recent study of 150 young children (12 to 38 months), we found that bottle fed children were almost three times as likely to be iron depleted compared with cup fed children (37% vs 18%). Thus, we hypothesize that an educational intervention designed to encourage timely bottle weaning will lead to a reduction in iron depletion.
Detailed description
We plan to undertake a randomized controlled trial to evaluate the effectiveness of an office-based educational intervention for the prevention of iron depletion in young children. Healthy children will be recruited from a community pediatric office which serves a diverse, urban population. Children will be randomized to the intervention education group or the control education group at 9 months of age. Blood work (\ 4mL) for complete blood count and ferritin along with additional measures such as transferrin, iron, and reticulocyte count will be obtained at 24 months of age. Rates of iron depletion and anemia will be compared in the two groups. The two groups will also have 25-hydroxy vitamin D, calcium and alkaline phosphatase levels analyzed at the 24 month visit to ensure that the intervention for prevention of iron depletion does not adversely affect these measures.
Interventions
OTHERHealthy milk intake
In addition to the standard nutrition counselling, the intervention group will receive specific information regarding healthy milk intake (2 cups per day, maximum 16 ounces) and the potential negative health effects of prolonged bottle use and excessive milk intake including anemia, iron depletion, and dental carries.
Parents of children will receive nutrition counselling via trained study personnel, including recommendations for iron containing food choices and timing of cow's milk introduction. This group will also receive a colourful nutrition book.
Sponsors
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
9 Months to 9 Months
Healthy volunteers
Yes
Inclusion criteria
* Children aged 9 months who are attending a routine primary care well-child visit. * Children who are in good general health. * Children whose parents provide informed consent to participate.
Exclusion criteria
* Children with chronic illness. * Children with birth weight less than 2.5 kg. * Children with previously diagnosed anemia (including known iron deficiency anemia). This includes children with marrow failure (aplastic anemia, Fanconi anemia), hemoglobinopathies (sickle cell disease, thalassemia), lead intoxication, sideroblastic anemia, megaloblastic anemia, enzymopathies (G6PD deficiency, pyruvate kinase deficiency), or membranopathies (hereditary spherocytosis). * Children currently receiving medications associated with anemia. This includes children taking antimetabolites or phenytoin. * Children currently receiving iron supplementation other than iron fortified formula.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Primary Outcome is Iron Depletion, and Will be Defined as Serum Ferritin <10 mcg/L. | Age 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Iron Deficiency (Defined as Serum Ferritin <10 mcg/L and MCV < 70 mcm3 Iron Deficiency. | Age 24 months |
| IDA (Hemoglobin < 110 g/L With Iron Deficiency) | Age 24 months |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group Standard nutrition counselling: Parents of children will receive nutrition counselling via trained study personnel based on the Canadian Paediatric Society Guidelines. Nutrition counselling occurs at the 9-month visit and is repeated at the 15-month visit if the child has not transitioned into the use of a cup. Recommendations include iron containing food choices and timing of cow's milk introduction. This group will also receive a colourful nutrition book. | 122 |
| Intervention Group Healthy milk intake: In addition to the standard nutrition counselling provided in the control group, the intervention group will receive specific information regarding healthy milk intake (2 cups per day, maximum 16 ounces) and the potential negative health effects of prolonged bottle use and excessive milk intake including anemia, iron depletion, and dental carries. | 129 |
| Total | 251 |
Baseline characteristics
| Characteristic | Total | Control Group | Intervention Group |
|---|---|---|---|
| Age, Categorical <=18 years | 251 Participants | 122 Participants | 129 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Bottle use Bottle Only | 121 participants | 60 participants | 61 participants |
| Bottle use Breast and Bottle | 41 participants | 15 participants | 26 participants |
| Bottle use Breast Only | 84 participants | 46 participants | 38 participants |
| Bottle use Information Not Available | 5 participants | 1 participants | 4 participants |
| Plan to bottle-wean by 2 years old No Information Available | 121 participants | 55 participants | 66 participants |
| Plan to bottle-wean by 2 years old Plan to Bottle Wean By 2 Years Old | 130 participants | 67 participants | 63 participants |
| Race/Ethnicity, Customized Asian | 30 participants | 18 participants | 12 participants |
| Race/Ethnicity, Customized Black | 13 participants | 6 participants | 7 participants |
| Race/Ethnicity, Customized Hispanic | 31 participants | 13 participants | 18 participants |
| Race/Ethnicity, Customized White | 177 participants | 85 participants | 92 participants |
| Sex: Female, Male Female | 119 Participants | 53 Participants | 66 Participants |
| Sex: Female, Male Male | 132 Participants | 69 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 122 | 0 / 129 |
| serious Total, serious adverse events | 0 / 122 | 0 / 129 |
Outcome results
Primary
The Primary Outcome is Iron Depletion, and Will be Defined as Serum Ferritin <10 mcg/L.
Time frame: Age 24 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group | The Primary Outcome is Iron Depletion, and Will be Defined as Serum Ferritin <10 mcg/L. | No Iron Depletion | 64 participants |
| Control Group | The Primary Outcome is Iron Depletion, and Will be Defined as Serum Ferritin <10 mcg/L. | Yes Iron Depletion | 13 participants |
| Control Group | The Primary Outcome is Iron Depletion, and Will be Defined as Serum Ferritin <10 mcg/L. | Unknown | 22 participants |
| Intervention Group | The Primary Outcome is Iron Depletion, and Will be Defined as Serum Ferritin <10 mcg/L. | Yes Iron Depletion | 10 participants |
| Intervention Group | The Primary Outcome is Iron Depletion, and Will be Defined as Serum Ferritin <10 mcg/L. | No Iron Depletion | 71 participants |
| Intervention Group | The Primary Outcome is Iron Depletion, and Will be Defined as Serum Ferritin <10 mcg/L. | Unknown | 21 participants |
p-value: 0.42Chi-squared
Secondary
IDA (Hemoglobin < 110 g/L With Iron Deficiency)
Time frame: Age 24 months
Secondary
Iron Deficiency (Defined as Serum Ferritin <10 mcg/L and MCV < 70 mcm3 Iron Deficiency.
Time frame: Age 24 months