NCT00399191

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_1

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

August 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2006

Completed
Last Updated

March 18, 2010

Status Verified

March 1, 2010

First QC Date

November 13, 2006

Last Update Submit

March 17, 2010

Conditions

Iron Deficiency Anemia

Keywords

anemiairon deficiency anemiairon deficiencyabsorptioniron absorptioniron uptake

Outcome Measures

Primary Outcomes (3)

  • initial mucosal uptake of iron

  • intra- and inter-individual variability

  • red cell incorporation of iron

Interventions

stable isotope of iron, dysprosiumDRUG

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ferritin \<40

You may not qualify if:

  • pregnant,
  • post-partum,
  • s/p GIT surgery,
  • known malabsorption,
  • coeliac disease,
  • Helicobacter pylori

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Southwestern

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Anemia, Iron-DeficiencyAnemiaIron Deficiencies

Interventions

Dysprosium

Condition Hierarchy (Ancestors)

Anemia, HypochromicHematologic DiseasesHemic and Lymphatic DiseasesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Lanthanoid Series ElementsMetals, Rare EarthElementsInorganic ChemicalsMetals

Study Officials

  • Morteza Janghorbani, PhD

    BioChemAnalysis Corp.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

November 13, 2006

First Posted

November 14, 2006

Study Start

August 1, 2006

Last Updated

March 18, 2010

Record last verified: 2010-03

Locations

US(1)