A Test of Iron Malabsorption in Patients With Iron Deficiency Anemia

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00399191
First received: November 13, 2006
Last updated: March 17, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention Phase
Iron Deficiency Anemia
Drug: stable isotope of iron, dysprosium
Phase 1

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

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • initial mucosal uptake of iron
  • intra- and inter-individual variability
  • red cell incorporation of iron

Estimated Enrollment: 15
Study Start Date: August 2006
  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ferritin <40

Exclusion Criteria:

  • pregnant,
  • post-partum,
  • s/p GIT surgery,
  • known malabsorption,
  • coeliac disease,
  • Helicobacter pylori
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00399191

Locations
United States, Texas
UT Southwestern
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Investigators
Principal Investigator: Morteza Janghorbani, PhD BioChemAnalysis Corp.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00399191     History of Changes
Other Study ID Numbers: R43 DK64495 (completed)
Study First Received: November 13, 2006
Last Updated: March 17, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
anemia
iron deficiency anemia
iron deficiency
absorption
iron absorption
iron uptake

Additional relevant MeSH terms:
Anemia
Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014