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Prevention of Iron Deficiency in 2nd Year of Life
This study is not yet open for participant recruitment.
Verified by Soroka University Medical Center, May 2007
First Received: May 24, 2007   No Changes Posted
Sponsored by: Soroka University Medical Center
Information provided by: Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT00479102
  Purpose

Healthy babies(age 8-18 months) following a routine blood count, with no anemia or iron deficiency, will be randomly placed in two groups. Group 1 will receive a 3 months preventive dose of an iron preparation (Ferripel 3 iron polysaccharide complex). Group 2 will be followed up as a control group.

Following a nutritional questionnair, parents of all babies will receive instruction regarding appropriate nutrition in the 2nd year of life. A follow-up blood count will be taken from all participating babies 3 months after recruitment. The study aims to evaluate effectiveness of iron supplementation in the 2nd year of life. The hypothesis is that babies who receive iron supplementation in the 2nd year of life are less likely to develop iron deficiency or anemia.


Condition Intervention Phase
Iron Deficiency
Anemia
Drug: Ferripel-3 - iron polysaccharide complex for prevention
Phase IV

MedlinePlus related topics: Anemia Dietary Supplements
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title: Effectiveness of Iron Supplementation in the Second Year of Life for Prevention of Iron Deficiency

Further study details as provided by Soroka University Medical Center:

Study Start Date: May 2007
  Eligibility

Ages Eligible for Study:   8 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy babies without iron deficiency

Exclusion Criteria:

  • Babies with iron deficiency or chronic diseases, premature babies and babies with hereditary hematological disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00479102

Contacts
Contact: Hanna Shalev, MD 972-52-8504058 hannash@clalit.org.il

Locations
Israel
Clalit Health Services Child Health Center
Rahat, Israel
Sponsors and Collaborators
Soroka University Medical Center
Investigators
Principal Investigator: Hanna Shalev, MD Clalit Health Services
  More Information

No publications provided

Study ID Numbers: sor448707ctil
Study First Received: May 24, 2007
Last Updated: May 24, 2007
ClinicalTrials.gov Identifier: NCT00479102     History of Changes
Health Authority: Israel: Ministry of Health

Keywords provided by Soroka University Medical Center:
Iron supplementation
Babies
Prevention

Study placed in the following topic categories:
Metabolic Diseases
Hematologic Diseases
Anemia
Trace Elements
Micronutrients
Iron Metabolism Disorders
Iron
Metabolic Disorder
Anemia, Iron-Deficiency

Additional relevant MeSH terms:
Metabolic Diseases
Hematologic Diseases
Growth Substances
Physiological Effects of Drugs
Anemia
Anemia, Hypochromic
Trace Elements
Micronutrients
Iron Metabolism Disorders
Iron
Pharmacologic Actions
Anemia, Iron-Deficiency

ClinicalTrials.gov processed this record on May 07, 2009