Treatment of Anemia in the 2nd Year of Life. Comparison of the Efficacy of Two Different Iron Preparations.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Soroka University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00248716
First received: November 3, 2005
Last updated: April 29, 2008
Last verified: April 2008
  Purpose

Healthy toddlers (age 9-18 month) following a routine blood count will be placed in three groups:

  1. Iron deficiency with no anemia
  2. anemia
  3. no anemia and no iron deficiency Following a nutritional questionnaire, parents of all toddlers will receive instruction regarding appropriate nutrition in the 2nd year of life. Groups 1 and 2 will randomly receive one of two preparations currently in use for treatment of iron deficiency in Israel (Aktiron 35 - Ferrous gluconate and Ferripel-3 - iron polysaccharide complex). Followup blood count will be taken 3 month after recruitment. The study aims to compare the effectiveness of the Iron preparations regarding compliance and efficacy.

The hypothesis is that a significant difference will be detected between the two preparations.


Condition Intervention Phase
Iron Deficiency
Anemia
Drug: Ferrous gluconate and iron polysaccharide complex
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • Hemoglobin [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: February 2007
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Ferrous gluconate and iron polysaccharide complex
    Children with anemia will receive 5mg per kg per day of one of study medications. Treatment period for 3 months
  Eligibility

Ages Eligible for Study:   9 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy toddlers age 9-18 months

Exclusion Criteria:

  • Toddlers with: chronic diseases, prematurity, inherited hematological disease.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00248716

Contacts
Contact: Jacob Urkin, MD, MPH 972-8-6477480 jacobur@clalit.org.il

Locations
Israel
Primary Pediatric Care Unit, Ben-Gurion University of the Negev Recruiting
Beer-Sheva, Israel, 84105
Contact: Jacob Urkin, MD, MPH    972-8-6477480    jacobur@clalit.org.il   
Sponsors and Collaborators
Soroka University Medical Center
Investigators
Principal Investigator: Jacob Urkin, MD, MPH Ben-Gurion University of the Negev
  More Information

No publications provided

Responsible Party: Dr Jacob Urkin, Ben-Gurion University of the Negev
ClinicalTrials.gov Identifier: NCT00248716     History of Changes
Other Study ID Numbers: sor458607ctil
Study First Received: November 3, 2005
Last Updated: April 29, 2008
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on August 28, 2014