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

NCT ID: NCT00907088

Last Updated: 2014-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 251 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2009-05-31

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.

Conditions

Iron Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

1

Group Type: ACTIVE_COMPARATOR

Standard nutrition counselling

Intervention Type: 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.

2

Group Type: EXPERIMENTAL

Healthy milk intake

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 9 Months
• Maximum Eligible Age: 9 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Patricia Parkin

Staff Paediatrician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patricia Parkin, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 20624802 (View on PubMed)

Other Identifiers

1000007781

Identifier Type: -

Identifier Source: org_study_id