NCT00456729

Brief Summary

Infants should receive prophylacatic iron supplementation since age 4 months till one year. Patients suffering from malabsorption, mainly Giardia infestation may develop iron deficiency resistent to further iron treatment. The purpose of this study is to assess the incidence of malabsorption in those infants and to examine the results of empiric treatment with metronidazole.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 5, 2007

Completed
Last Updated

April 5, 2007

Status Verified

January 1, 2007

First QC Date

April 4, 2007

Last Update Submit

April 4, 2007

Conditions

Iron DeficiencyMalabsorption

Keywords

Iron deficiencyMalabsorptionGiardiasis

Outcome Measures

Primary Outcomes (1)

  • Hgb level

Secondary Outcomes (2)

  • Iron level

  • Ferritin Level

Interventions

MetronidazoleDRUG
Blood testsPROCEDURE

Eligibility Criteria

Age6 Months - 4 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • All infants referred to the Pediatric Hematology Unit because lack of response to iron treatment.

You may not qualify if:

  • Patients diagnosed with specific malabsorption causes like Celiac or Cystic Fibrosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center

Afula, 18101, Israel

Location

MeSH Terms

Conditions

Iron DeficienciesMalabsorption SyndromesGiardiasis

Interventions

MetronidazoleHematologic Tests

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases, ParasiticParasitic DiseasesInfectionsProtozoan Infections

Intervention Hierarchy (Ancestors)

NitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Ariel Koren, MD

    Pediatric Hematology Unit, Ha'Emek Medical Center

    STUDY DIRECTOR

  • Carina Levin, MD

    Pediatric Hematology Unit - Ha'Emek Medical Center

    PRINCIPAL INVESTIGATOR

  • Tania Hanchis, MD

    Pediatric Dpt B - Ha'Emek Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 4, 2007

First Posted

April 5, 2007

Study Start

May 1, 2006

Study Completion

July 1, 2006

Last Updated

April 5, 2007

Record last verified: 2007-01

Locations

IL(1)