Nutritional Education and the Prevention of Iron Depletion in Children 9 Months to 2 Years

Iron Deficiency Clinical Trial

Official title:

Nutritional Education and the Prevention of Iron Depletion in Children 9 Months to 2 Years: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00907088
• Other study ID #: 1000007781
• Status: Completed
• Phase: N/A
• First received: May 21, 2009
• Last updated: March 12, 2014
• Start date: January 2006
• Est. completion date: May 2009

Study information

• Verified date: March 2014
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Months to 9 Months

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Primary Outcome is Iron Depletion, and Will be Defined as Serum Ferritin <10 mcg/L.		Age 24 months	Yes
Secondary	Iron Deficiency (Defined as Serum Ferritin <10 mcg/L and MCV < 70 mcm3 Iron Deficiency.		Age 24 months	Yes
Secondary	IDA (Hemoglobin < 110 g/L With Iron Deficiency)		Age 24 months	Yes