Prevention of Iron Deficiency in 2nd Year of Life

May 24, 2007 updated by: Soroka University Medical Center

Effectiveness of Iron Supplementation in the Second Year of Life for Prevention of Iron Deficiency

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Rahat, Israel
        • Clalit Health Services Child Health Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy babies without iron deficiency

Exclusion Criteria:

  • Babies with iron deficiency or chronic diseases, premature babies and babies with hereditary hematological disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soroka University Medical Center

Investigators

  • Principal Investigator: Hanna Shalev, MD, Clalit Health Services

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Study Registration Dates

First Submitted

May 24, 2007

First Submitted That Met QC Criteria

May 24, 2007

First Posted (Estimate)

May 25, 2007

Study Record Updates

Last Update Posted (Estimate)

May 25, 2007

Last Update Submitted That Met QC Criteria

May 24, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sor448707ctil

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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