NCT00907088

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
251

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 22, 2009

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

April 16, 2014

Completed
Last Updated

April 16, 2014

Status Verified

March 1, 2014

Enrollment Period

3.3 years

First QC Date

May 21, 2009

Results QC Date

December 2, 2013

Last Update Submit

March 12, 2014

Conditions

Iron Deficiency

Keywords

Iron depletionChildrenEducational interventionOffice-based

Outcome Measures

Primary Outcomes (1)

  • The Primary Outcome is Iron Depletion, and Will be Defined as Serum Ferritin <10 mcg/L.

    Age 24 months

Secondary Outcomes (2)

  • Iron Deficiency (Defined as Serum Ferritin <10 mcg/L and MCV < 70 mcm3 Iron Deficiency.

    Age 24 months

  • IDA (Hemoglobin < 110 g/L With Iron Deficiency)

    Age 24 months

Study Arms (2)

1

ACTIVE COMPARATOR
Other: Standard nutrition counselling

2

EXPERIMENTAL
Other: Healthy milk intake

Interventions

Healthy milk intakeOTHER

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.

2
Standard nutrition counsellingOTHER

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.

1

Eligibility Criteria

Age9 Months - 9 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

Related Publications (1)

  • 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.

    PMID: 20624802DERIVED

MeSH Terms

Conditions

Iron Deficiencies

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
Dr. Patricia Parkin
Organization
The Hospital for Sick Children
patricia.parkin@sickkids.ca
416-813-7654

Study Officials

  • Patricia Parkin, MD

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Paediatrician

Study Record Dates

First Submitted

May 21, 2009

First Posted

May 22, 2009

Study Start

January 1, 2006

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

April 16, 2014

Results First Posted

April 16, 2014

Record last verified: 2014-03

Locations

CA(1)