NCT00202488

Brief Summary

The purpose of this study is to determine if Helicobacter pylori (H. pylori) gastritis results in abnormal iron metabolism in patients with iron deficiency anemia (IDA), and to determine if this is due to strain variations in the H. pylori organism.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2002

Longer than P75 for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

July 30, 2008

Status Verified

July 1, 2008

First QC Date

September 13, 2005

Last Update Submit

July 29, 2008

Conditions

Iron Deficiency AnemiaHelicobacter Pylori Infection

Keywords

anemia, iron-deficiencyHelicobacter pylori

Outcome Measures

Primary Outcomes (4)

  • Difference in iron absorption (Cmax) for H. pylori infected and uninfected IDA patients.

  • Change following H. pylori treatment in the iron absorption (Cmax) for H. pylori infected IDA patients.

  • Difference in the presence of genes related to iron metabolism for H. pylori-infected IDA patients vs. non-anemic controls.

  • Difference in gastritis pattern between H. pylori-infected IDA patients and non-anemic controls.

Secondary Outcomes (3)

  • Difference in gastritis severity between H. pylori-infected IDA patients and non-anemic controls.

  • Difference in gastric iron concentration.

  • Change in Hct and ferritin values following treatment.

Interventions

H. pylori treatmentDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \> 18 years
  • iron deficiency anemia (IDA) defined as: Hgb \< 14 g/L for men and 12 g/L for women, and a serum ferritin level less than 45 ug/L

You may not qualify if:

  • Obvious non-GI cause of blood loss
  • Chronic renal failure (BUN\>60, Creatinine \> 4)
  • Hemolytic anemia, thalassemia, aplastic anemia
  • Known alcoholism or cirrhosis of the liver
  • Regular use (\>3x weekly) of NSAIDS
  • Prior gastric resection
  • Celiac disease
  • Known GI or hematologic malignancy
  • Known inflammatory bowel disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • David Kearney, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

November 1, 2002

Study Completion

September 1, 2007

Last Updated

July 30, 2008

Record last verified: 2008-07

Locations

US(1)