A Test of Iron Malabsorption in Patients With Iron Defici... | NCT00399191

Studies
A Test of Iron Malabsorption in Patients With Iron Deficiency Anemia

NCT00399191

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Status

Completed

Last Update Posted

Mar 18, 2010Estimated

Enrollment

15Estimated

Phase

Phase 1

Conditions

Iron Deficiency Anemia

Interventions

stable isotope of iron, dysprosium

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R43DK064495	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Aug 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 13, 2006

First Submission Date that Met QC Criteria

Nov 13, 2006

First Posted Date

Nov 14, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2010

Last Update Posted Date

Mar 18, 2010Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Name	Type	Description	Arm Group Labels	Other Names
stable isotope of iron, dysprosium	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
initial mucosal uptake of iron
intra- and inter-individual variability
red cell incorporation of iron

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ferritin <40

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Morteza Janghorbani, PhD	BioChemAnalysis Corp.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UT Southwestern		Dallas	Texas	75390	United States

Condition Browse Module

MeSH Terms

ID	Term
D018798	Anemia, Iron-Deficiency
D000740	Anemia
D000090463	Iron Deficiencies

Ancestor Terms

ID	Term
D000747	Anemia, Hypochromic
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D019189	Iron Metabolism Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004419	Dysprosium

Ancestor Terms

ID	Term
D028581	Lanthanoid Series Elements
D008674	Metals, Rare Earth
D004602	Elements
D007287	Inorganic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided