Incidence of Iron Deficiency Anemia in Toddlers

Healthy Infants Clinical Trial

Official title:

Incidence of Iron Deficiency Anemia in Toddlers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00971672
• Other study ID #: 0024/09-EMC
• Status: Completed
• Phase: N/A
• First received: September 3, 2009
• Last updated: August 30, 2015
• Start date: February 2010
• Est. completion date: August 2014

Study information

• Verified date: August 2015
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Months to 36 Months

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Healthy Infants

Intervention

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.

Locations

Country	Name	City	State
Israel	Pediatric Hematology Unit - Ha'Emek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of anemia (Hemoglobin below normal for age) and Iron deficiency (Low ferritin value)		One year	No