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Prevention of Iron Deficiency in 2nd Year of Life

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by Soroka University Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00479102
First received: May 24, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effectiveness of Iron Supplementation in the Second Year of Life for Prevention of Iron Deficiency

Resource links provided by NLM:

MedlinePlus related topics: Anemia Iron
Drug Information available for: Niferex
U.S. FDA Resources

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 Not yet recruiting
Rahat, Israel
Contact: Hanna Shalev, MD     972-52-8504058     hannash@clalit.org.il    
Sponsors and Collaborators
Soroka University Medical Center
Investigators
Principal Investigator: Hanna Shalev, MD Clalit Health Services
  More Information

No publications provided

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

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

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

ClinicalTrials.gov processed this record on May 19, 2013