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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Patricia Parkin, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00907088
First received: May 21, 2009
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Iron Deficiency
Other: Healthy milk intake
Other: Standard nutrition counselling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Nutritional Education and the Prevention of Iron Depletion in Children 9 Months to 2 Years: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • The Primary Outcome is Iron Depletion, and Will be Defined as Serum Ferritin <10 mcg/L. [ Time Frame: Age 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Iron Deficiency (Defined as Serum Ferritin <10 mcg/L and MCV < 70 mcm3 Iron Deficiency. [ Time Frame: Age 24 months ] [ Designated as safety issue: Yes ]
  • IDA (Hemoglobin < 110 g/L With Iron Deficiency) [ Time Frame: Age 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 251
Study Start Date: January 2006
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 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.
Experimental: 2 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.

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.

  Eligibility

Ages Eligible for Study:   9 Months to 9 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00907088

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Patricia Parkin, MD The Hospital for Sick Children
  More Information

No publications provided by The Hospital for Sick Children

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Patricia Parkin, Staff Paediatrician, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00907088     History of Changes
Other Study ID Numbers: 1000007781
Study First Received: May 21, 2009
Results First Received: December 2, 2013
Last Updated: March 12, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
Iron depletion
Children
Educational intervention
Office-based
Iron Depletion

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014