Anemia, Iron-DeficiencyNCT00498511
Gastrointestinal Evaluation in Young Men With Iron Deficiency Anemia
An observational study of Anemia, Iron-Deficiency, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Both upper gastrointestinal endoscopy and colonoscopy are recommended in men and post-menopausal women with iron deficiency anemia. Due to lack of data on the yield of these endoscopies in young men, they are currently investigated as older men. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Anemia, Iron-Deficiency
- What is being tested?
- upper gastrointestinal endoscopy, colonoscopy
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Aug 2007to not given
- Phase
- Observational
- 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 18 to 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Men < 40 years old of age with iron deficiency.
- hemoglobin level less than 13 gr/dl documented during the 2 years prior to entering the study with one of the following: 1) iron level less than 45 μg /dl and transferrin saturation less than 10%; 2) ferritin level less than 20 μg/L (both documented during the 4 months prior to entering the study).
Who cannot join
- Previously diagnosed disease that explain iron deficiency anemia
- Colonoscopy performed during the last 4 years
- Upper gastrointestinal endoscopy performed during the last 2 years
Trial locations and contacts
1 site in 1 country.
Israel1 site
Institute of Gastroenterology and Liver Diseases, Assaf harofeh Medical Center
Tsrifin, 70300
Alain Nimrod Kimchi, M.D.
About this study
Official title: Prospective Evaluation of the Gastrointestinal Tract in Young Men With Iron Deficiency Anemia
Both upper gastrointestinal endoscopy and colonoscopy are recommended in men and post-menopausal women with iron deficiency anemia. Due to lack of data on the yield of these endoscopies in young men, they are currently investigated as older men. The aim of this study is to evaluate prospectively the prevalence of various gastrointestinal lesions in young men with iron deficiency anemia. Our hypothesis is that the diagnostic yield of colonoscopy in young anemic men without gastrointestinal symptoms is very low, especially if a potential lesion is detected during upper gastrointestinal endoscopy. Therefore, this study will try to identify predicting factors regarding the yield of both endoscopies. Another purpose is to evaluate the outcome of patients with negative endoscopic results, during a follow-up of two years.
- Conditions
- Anemia, Iron-Deficiency
- Being tested
- upper gastrointestinal endoscopy, colonoscopy
- Keywords
- Anemia, Iron-Deficiency, Endoscopy, Gastrointestinal, Male, aged 18 to 40
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
upper gastrointestinal endoscopy, colonoscopyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2007 (estimated)
- Study startAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia, Iron-DeficiencyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Investigators
- Alain Nimrod Kimchi, M.D., Principal investigator, Institute of Gastroenterology and Liver Diseases, Assaf-Harofeh Medical Center, 70300 Zerifin, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00498511
- Sponsor's protocol ID
- 64/07
- Status last verified
- Jun 2007
- First submitted
- 8 Jul 2007
- Last updated
- 13 Jul 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Gastrointestinal Tract in Young Men With Iron Deficiency Anemia
- ClinicalTrials.gov ID
- NCT00498511
- Acronym / sponsor ID
- 64/07
- Conditions
- Anemia, Iron-Deficiency
- Keywords
- Anemia, Iron-Deficiency, Endoscopy, Gastrointestinal, Male, aged 18 to 40
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Aug 2007
- First posted
- 10 Jul 2007 (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.
Both upper gastrointestinal endoscopy and colonoscopy are recommended in men and post-menopausal women with iron deficiency anemia. Due to lack of data on the yield of these endoscopies in young men, they are currently investigated as older men. The aim of this study is to evaluate prospectively the prevalence of various gastrointestinal lesions in young men with iron deficiency anemia. Our hypothesis is that the diagnostic yield of colonoscopy in young anemic men without gastrointestinal symptoms is very low, especially if a potential lesion is detected during upper gastrointestinal endoscopy. Therefore, this study will try to identify predicting factors regarding the yield of both endoscopies. Another purpose is to evaluate the outcome of patients with negative endoscopic results, during a follow-up of two years.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Men < 40 years old of age with iron deficiency.
- hemoglobin level less than 13 gr/dl documented during the 2 years prior to entering the study with one of the following: 1) iron level less than 45 μg /dl and transferrin saturation less than 10%; 2) ferritin level less than 20 μg/L (both documented during the 4 months prior to entering the study).
Key exclusion criteria (3 listed)
- Previously diagnosed disease that explain iron deficiency anemia
- Colonoscopy performed during the last 4 years
- Upper gastrointestinal endoscopy performed during the last 2 years
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 |
|---|---|---|
| upper gastrointestinal endoscopy, colonoscopy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2007.
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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.
Alain Nimrod Kimchi, M.D. principal investigator
Institute of Gastroenterology and Liver Diseases, Assaf-Harofeh Medical Center, 70300 Zerifin, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia, Iron-Deficiency, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Jul 2007. 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 Israel. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alain Nimrod Kimchi, M.D. (972-08-9779722, nimrodk@asaf.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 13 Jul 2007.