NCT00248716

Brief Summary

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

  1. 1.Iron deficiency with no anemia
  2. 2.anemia
  3. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 2005

Completed
1.2 years until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Last Updated

May 6, 2008

Status Verified

April 1, 2008

Enrollment Period

2.2 years

First QC Date

November 3, 2005

Last Update Submit

April 29, 2008

Conditions

Iron DeficiencyAnemia

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin

    3 months

Interventions

Ferrous gluconate and iron polysaccharide complexDRUG

Children with anemia will receive 5mg per kg per day of one of study medications. Treatment period for 3 months

Eligibility Criteria

Age9 Months - 18 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Healthy toddlers age 9-18 months

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Beersheba, 84105, Israel

RECRUITING

MeSH Terms

Conditions

Iron DeficienciesAnemia

Interventions

ferrous gluconateNiferex

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Jacob Urkin, MD, MPH

    Ben-Gurion University of the Negev

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacob Urkin, MD, MPH

CONTACT

972-8-6477480jacobur@clalit.org.il

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 3, 2005

First Posted

November 4, 2005

Study Start

February 1, 2007

Primary Completion

April 1, 2009

Last Updated

May 6, 2008

Record last verified: 2008-04

Locations

IL(1)