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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthy milk intake | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Outcome is Iron Depletion, and Will be Defined as Serum Ferritin <10 mcg/L. | Age 24 months |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia Parkin, MD | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Toronto | Ontario | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20624802 | Derived | Maguire JL, Birken CS, Jacobson S, Peer M, Taylor C, Khambalia A, Mekky M, Thorpe KE, Parkin P. Office-based intervention to reduce bottle use among toddlers: TARGet Kids! Pragmatic, randomized trial. Pediatrics. 2010 Aug;126(2):e343-50. doi: 10.1542/peds.2009-3583. Epub 2010 Jul 12. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Standard nutrition counselling: 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. |
| FG001 | Intervention Group | Healthy 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | All participants were 9 months of age. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Primary Outcome is Iron Depletion, and Will be Defined as Serum Ferritin <10 mcg/L. | Posted | Number | participants | Age 24 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Standard nutrition counselling: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Patricia Parkin | The Hospital for Sick Children | 416-813-7654 | 301544 | patricia.parkin@sickkids.ca |
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| ID | Term |
|---|---|
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Standard nutrition counselling | Other | 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. |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Bottle use | Number | participants |
|
| Plan to bottle-wean by 2 years old | Number | participants |
|
|
|
|
| Secondary | Iron Deficiency (Defined as Serum Ferritin <10 mcg/L and MCV < 70 mcm3 Iron Deficiency. | Not Posted | Age 24 months |
| Secondary | IDA (Hemoglobin < 110 g/L With Iron Deficiency) | Not Posted | Age 24 months |
| 0 |
| 122 |
| 0 |
| 122 |
| EG001 | Intervention Group | Healthy 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. | 0 | 129 | 0 | 129 |
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