Incidence of Iron Deficiency Anemia in Toddlers

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dr Koren Ariel, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00971672
First received: September 3, 2009
Last updated: July 16, 2013
Last verified: July 2013
  Purpose

The frequency of iron deficiency anemia was extensively studied in infants on the first year of life. There is not enough information about the frequency of iron deficiency during the second and third years of life. In a previous study performed in Israel and published in Pediatrics 2006 the incidence of anemia does not decrease towards age 18 months. Then there is reasonable to study the iron deficiency frequency beyond this age.


Condition Intervention
Healthy Infants
Other: Questionnaire filling and laboratory analysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Incidence of Iron Deficiency Anemia in Toddlers

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • Frequency of anemia (Hemoglobin below normal for age) and Iron deficiency (Low ferritin value) [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: September 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Toddlers from Jewish origin
Toddlers from Jewish origin aged 18 to 36 months
Other: Questionnaire filling and laboratory analysis

A questionnaire that included demographic characteristics, nutrition and iron supplementation in the first year, growth status, and laboratory results will be filled for each patient.

The laboratory analysis will include complete blood count and serum ferritin analysis.

Toddlers from non Jewish origin
Toddlers aged 18 to 36 months belonging to non Jewish (Arab) population
Other: Questionnaire filling and laboratory analysis

A questionnaire that included demographic characteristics, nutrition and iron supplementation in the first year, growth status, and laboratory results will be filled for each patient.

The laboratory analysis will include complete blood count and serum ferritin analysis.


Detailed Description:

The purpose of this study is to analyze the frequency of Iron deficiency anemia in a group of 400 toddles from age 18 months to 36 months.

Two groups of children will be included, 200 children from Jewish origin and 200 from non Jewish origin, mostly Arabs.

A questionnaire that included demographic characteristics, nutrition and iron supplementation in the first year, growth status, and laboratory results will be filled for each patient.

The laboratory analysis will include complete blood count and serum ferritin analysis.

Children that were previously diagnosed suffering from iron deficiency, children suffering from chronic diseases or were born premature will not be included in the study.

  Eligibility

Ages Eligible for Study:   18 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

The purpose of this study is to analyze the frequency of Iron deficiency anemia in a group of 400 toddles from age 18 months to 36 months.

Two groups of children will be included, 200 children from Jewish origin and 200 from non Jewish origin, mostly Arabs.

Children that were previously diagnosed suffering from iron deficiency, children suffering from chronic diseases or were born premature will not be included in the study.

Criteria

Inclusion Criteria:

  • Healthy children that attend the pediatric community clinics.

Exclusion Criteria:

  • Children that were previously diagnosed suffering from iron deficiency.
  • Children suffering from chronic diseases or were born premature will not be included in the study.
  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: NCT00971672

Locations
Israel
Pediatric Hematology Unit - Ha'Emek Medical Center
Afula, Israel, 18101
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: Ariel Koren, MD Pediatric Dpt B and Pediatric Hemaology Unit - Ha'Emek Medical Center - Afula - Israel
  More Information

No publications provided

Responsible Party: Dr Koren Ariel, Head of Pediatric Hematology Unit and Pediatric Dpt B, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT00971672     History of Changes
Other Study ID Numbers: 0024/09-EMC
Study First Received: September 3, 2009
Last Updated: July 16, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by HaEmek Medical Center, Israel:
Infants
Iron Deficiency
Anemia
Healthy infants that attend the pediatric community clinics

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia
Anemia, Hypochromic
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014