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NCT00399191 Clinical Trial

A Test of Iron Malabsorption in Patients With Iron Deficiency Anemia

Iron Deficiency Anemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00399191
Other study ID # R43 DK64495 (completed)
Secondary ID
Status Completed
Phase Phase 1
First received November 13, 2006
Last updated March 17, 2010
Start date August 2006

Study information
Verified date March 2010
Source National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria:

- ferritin <40

Exclusion Criteria:

- pregnant,

- post-partum,

- s/p GIT surgery,

- known malabsorption,

- coeliac disease,

- Helicobacter pylori

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• stable isotope of iron, dysprosium

Locations
Country Name City State
United States UT Southwestern Dallas Texas

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary initial mucosal uptake of iron
Primary intra- and inter-individual variability
Primary red cell incorporation of iron
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