Incidence of Iron Deficiency Anemia in Toddlers

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2009 by HaEmek Medical Center, Israel.
Recruitment status was Not yet recruiting

Sponsor:

Information provided by:

HaEmek Medical Center, Israel

ClinicalTrials.gov Identifier:

NCT00971672

First received: September 3, 2009

Last updated: September 10, 2009

Last verified: September 2009

History of Changes

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:

MedlinePlus related topics: Anemia Iron

U.S. FDA Resources

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:	September 2010
Estimated Primary Completion Date:	September 2010 (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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00971672

Contacts

Contact: Ariel Koren, MD

972-4-6495576 ext 5576

koren_a@clalit.org.il

Locations

Israel
Pediatric Hematology Unit - Ha'Emek Medical Center	Not yet recruiting
Afula, Israel, 18101
Contact: Ariel Koren, MD 972-4-6495576 ext 5576 koren_a@clalit.org.il
Principal Investigator: Ariel Koren, MD
Sub-Investigator: Carina Levin, MD

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:	Materna Research Institute for Promotion of Infant Nutrition in Israel
ClinicalTrials.gov Identifier:	NCT00971672 History of Changes
Other Study ID Numbers:	0024/09-EMC
Study First Received:	September 3, 2009
Last Updated:	September 10, 2009
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
Anemia, Iron-Deficiency
Anemia, Hypochromic
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases

Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013

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