Iron Deficiency AnemiaPhase 1NCT00399191
A Test of Iron Malabsorption in Patients With Iron Deficiency Anemia
A Phase 1 study testing stable isotope of iron, dysprosium in people with Iron Deficiency Anemia, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- stable isotope of iron, dysprosium
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- ferritin <40
Who cannot join
- pregnant,
- post-partum,
- s/p GIT surgery,
- known malabsorption,
- coeliac disease,
- Helicobacter pylori
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Iron Deficiency Anemia
- Being tested
- stable isotope of iron, dysprosium
- Keywords
- anemia, iron deficiency anemia, iron deficiency, absorption, iron absorption, iron uptake
- Medical subject headings
- Anemia, Iron-Deficiency, Anemia, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stable isotope of iron, dysprosiumDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
initial mucosal uptake of iron
intra- and inter-individual variability
red cell incorporation of iron
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2006 (estimated)
- Study startAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Morteza Janghorbani, PhD, Principal investigator, BioChemAnalysis Corp.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00399191
- Sponsor's protocol ID
- R43 DK64495 (completed)
- Other IDs
- R43DK064495
- Status last verified
- Mar 2010
- First submitted
- 13 Nov 2006
- Last updated
- 18 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Test of Iron Malabsorption in Patients With Iron Deficiency Anemia
- ClinicalTrials.gov ID
- NCT00399191
- Acronym / sponsor ID
- R43 DK64495 (completed)
- Conditions
- Iron Deficiency Anemia
- Keywords
- anemia, iron deficiency anemia, iron deficiency, absorption, iron absorption, iron uptake
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Aug 2006
- First posted
- 14 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ferritin <40
Key exclusion criteria (6 listed)
- pregnant,
- post-partum,
- s/p GIT surgery,
- known malabsorption,
- coeliac disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stable isotope of iron, dysprosium | Drug | – |
Primary outcome
initial mucosal uptake of iron
intra- and inter-individual variability
red cell incorporation of iron
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morteza Janghorbani, PhD principal investigator
BioChemAnalysis Corp.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing stable isotope of iron, dysprosium in people with Iron Deficiency Anemia, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
initial mucosal uptake of iron. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2010; AzTrials last refreshed its copy on 7 Nov 2026.