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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00907088
First Posted: May 22, 2009
Last Update Posted: April 16, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Patricia Parkin, The Hospital for Sick Children
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Patricia Parkin, 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 ]

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

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

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Ages Eligible for Study:   9 Months to 9 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: May 21, 2009
First Posted: May 22, 2009
Results First Submitted: December 2, 2013
Results First Posted: April 16, 2014
Last Update Posted: April 16, 2014
Last Verified: March 2014

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

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