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NCT00248716 Clinical Trial

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

Anemia Clinical Trial

Clinical Trial Details — Status: Unknown status

Administrative data
NCT number NCT00248716
Other study ID # sor458607ctil
Secondary ID
Status Unknown status
Phase Phase 4
First received November 3, 2005
Last updated April 29, 2008
Start date February 2007

Study information
Verified date April 2008
Source Soroka University Medical Center
Contact Jacob Urkin, MD, MPH
Phone 972-8-6477480
Email jacobur@clalit.org.il
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Unknown status
Enrollment 200
Est. completion date
Est. primary completion date April 2009
Accepts healthy volunteers No
Gender All
Age group 9 Months to 18 Months
Eligibility Inclusion Criteria:

- Healthy toddlers age 9-18 months

Exclusion Criteria:

- Toddlers with: chronic diseases, prematurity, inherited hematological disease.

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Israel Primary Pediatric Care Unit, Ben-Gurion University of the Negev Beer-Sheva

Sponsors (1)
Lead Sponsor Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hemoglobin 3 months
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