Back to resultsA Test of Iron Malabsorption in Patients With Iron Deficiency Anemia
Primary Purpose
Iron Deficiency Anemia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
stable isotope of iron, dysprosium
Sponsored by
About this trial
This is an interventional diagnostic trial for Iron Deficiency Anemia focused on measuring anemia, iron deficiency anemia, iron deficiency, absorption, iron absorption, iron uptake
Eligibility Criteria
Inclusion Criteria:
- ferritin <40
Exclusion Criteria:
- pregnant,
- post-partum,
- s/p GIT surgery,
- known malabsorption,
- coeliac disease,
- Helicobacter pylori
Sites / Locations
- UT Southwestern
Outcomes
Primary Outcome Measures
initial mucosal uptake of iron
intra- and inter-individual variability
red cell incorporation of iron
Secondary Outcome Measures
Full Information
NCT ID
NCT00399191
First Posted
November 13, 2006
Last Updated
March 17, 2010
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT00399191
Brief Title
A Test of Iron Malabsorption in Patients With Iron Deficiency Anemia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
5. Study Description
Brief Summary
The objective of the study is to develop a simple, noninvasive test for evaluation of iron absorption as a tool to determine the cause of iron deficiency anemia. Healthy, premenopausal women with iron deficiency with or without anemia will be recruited for the study. Participants will, over the course of two months, ingest an iron solution three times; after each iron ingestion, participants will collect their stool and bring it to the study investigators for assessment of iron content.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia
Keywords
anemia, iron deficiency anemia, iron deficiency, absorption, iron absorption, iron uptake
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
stable isotope of iron, dysprosium
Primary Outcome Measure Information:
Title
initial mucosal uptake of iron
Title
intra- and inter-individual variability
Title
red cell incorporation of iron
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
ferritin <40
Exclusion Criteria:
pregnant,
post-partum,
s/p GIT surgery,
known malabsorption,
coeliac disease,
Helicobacter pylori
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morteza Janghorbani, PhD
Organizational Affiliation
BioChemAnalysis Corp.
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Test of Iron Malabsorption in Patients With Iron Deficiency Anemia
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