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

This study has been completed.
Sponsor:
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00907088
First received: May 21, 2009
Last updated: May 25, 2009
Last verified: May 2009

May 21, 2009
May 25, 2009
January 2006
May 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00907088 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Nutritional Education and the Prevention of Iron Depletion in Children 9 Months to 2 Years
Nutritional Education and the Prevention of Iron Depletion in Children 9 Months to 2 Years: a Randomized Controlled Trial

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Iron Deficiency
  • 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.
  • 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.
  • Active Comparator: 1
    Intervention: Other: Standard nutrition counselling
  • Experimental: 2
    Intervention: Other: Healthy milk intake
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. Epub 2010 Jul 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
253
May 2009
May 2009   (final data collection date for primary outcome measure)

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.
Both
9 Months to 9 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00907088
1000007781
No
Patricia Parkin, MD, FRCPC/ principal investigator, Hospital for Sick Children
The Hospital for Sick Children
Not Provided
Principal Investigator: Patricia Parkin, MD The Hospital for Sick Children
The Hospital for Sick Children
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP