Treatment of Anemia in the 2nd Year of Life. Comparison o... | NCT00248716

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

NCT00248716

Sponsor

Soroka University Medical Center

Status

Unknown status

Last Update Posted

May 6, 2008Estimated

Enrollment

200Estimated

Phase

Phase 4

Conditions

Iron Deficiency
Anemia

Interventions

Ferrous gluconate and iron polysaccharide complex

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2007

Primary Completion Date

Apr 2009Estimated

Completion Date

Not provided

First Submitted Date

Nov 3, 2005

First Submission Date that Met QC Criteria

Nov 3, 2005

First Posted Date

Nov 4, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2008

Last Update Posted Date

May 6, 2008Estimated

Description Module

Brief Summary

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

Iron deficiency with no anemia
anemia
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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ferrous gluconate and iron polysaccharide complex	Drug	Children with anemia will receive 5mg per kg per day of one of study medications. Treatment period for 3 months

Measure	Description	Time Frame
Hemoglobin		3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy toddlers age 9-18 months

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Months

Maximum Age

18 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jacob Urkin, MD, MPH	Contact	972-8-6477480		jacobur@clalit.org.il

Overall Officials

Name	Affiliation	Role
Jacob Urkin, MD, MPH	Ben-Gurion University of the Negev	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Primary Pediatric Care Unit, Ben-Gurion University of the Negev	Recruiting	Beersheba		84105	Israel

Type	Date	Date Unknown
Release	Jul 15, 2012
Reset	Aug 16, 2012
Release	Nov 17, 2015
Reset	Dec 18, 2015

Submission Tracking

Estimated Results First Submitted Date

Jul 15, 2012

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 15, 2012			Aug 16, 2012
Nov 17, 2015

Condition Browse Module

MeSH Terms

ID	Term
D000090463	Iron Deficiencies
D000740	Anemia

Ancestor Terms

ID	Term
D019189	Iron Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C011819	ferrous gluconate
C078972	Niferex

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided