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

NCT ID: NCT00248716

Last Updated: 2008-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Iron Deficiency Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy toddlers age 9-18 months

Exclusion Criteria

* Toddlers with: chronic diseases, prematurity, inherited hematological disease.
Minimum Eligible Age

9 Months

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Soroka University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Ben-Gurion University of the Negev

Principal Investigators

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Jacob Urkin, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Ben-Gurion University of the Negev

Locations

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Primary Pediatric Care Unit, Ben-Gurion University of the Negev

Beersheba, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Jacob Urkin, MD, MPH

Role: CONTACT

Phone: 972-8-6477480

Email: [email protected]

Facility Contacts

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Jacob Urkin, MD, MPH

Role: primary

Other Identifiers

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sor458607ctil

Identifier Type: -

Identifier Source: org_study_id