Iron DeficiencyNCT00456729
Malabsorption as a Cause of Iron Treatment Failure in Infants
A study testing Metronidazole and Blood tests in people with Iron Deficiency and Malabsorption, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
Infants should receive prophylacatic iron supplementation since age 4 months till one year. Patients suffering from malabsorption, mainly Giardia infestation may develop iron deficiency resistent to further iron treatment. Read more about this study
- Who is it for?
- Ages 6 months to 4 years
- Conditions the study is for
- Iron Deficiency, Malabsorption
- What is being tested?
- Metronidazole and Blood tests
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- May 2006to Jul 2006
- Phase
- Interventional
- 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 6 months to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All infants referred to the Pediatric Hematology Unit because lack of response to iron treatment.
Who cannot join
- Patients diagnosed with specific malabsorption causes like Celiac or Cystic Fibrosis.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center
Afula, 18101
About this study
Official title: Malabsorption as a Cause of Iron Treatment Failure in Infants - A Clinical Observational Study
Infants should receive prophylacatic iron supplementation since age 4 months till one year. Patients suffering from malabsorption, mainly Giardia infestation may develop iron deficiency resistent to further iron treatment. The purpose of this study is to assess the incidence of malabsorption in those infants and to examine the results of empiric treatment with metronidazole.
- Conditions
- Iron Deficiency, Malabsorption
- Being tested
- Metronidazole, Blood tests
- Keywords
- Iron deficiency, Malabsorption, Giardiasis
- Medical subject headings
- Iron Deficiencies, Malabsorption Syndromes, Giardiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetronidazoleDrug
Blood testsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Hgb level
Secondary outcomes (2)
Iron level
Ferritin Level
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2007 (estimated)
- Study startMay 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Investigators
- Ariel Koren, MD, Study director, Pediatric Hematology Unit, Ha'Emek Medical CenterCarina Levin, MD, Principal investigator, Pediatric Hematology Unit - Ha'Emek Medical CenterTania Hanchis, MD, Principal investigator, Pediatric Dpt B - Ha'Emek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00456729
- Sponsor's protocol ID
- 4150905.EMC
- Status last verified
- Jan 2007
- First submitted
- 4 Apr 2007
- Last updated
- 5 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Malabsorption as a Cause of Iron Treatment Failure in Infants - A Clinical Observational Study
- ClinicalTrials.gov ID
- NCT00456729
- Acronym / sponsor ID
- 4150905.EMC
- Conditions
- Iron Deficiency, Malabsorption
- Keywords
- Iron deficiency, Malabsorption, Giardiasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- May 2006
- Study completion
- Jul 2006 (actual)
- First posted
- 5 Apr 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.
Infants should receive prophylacatic iron supplementation since age 4 months till one year. Patients suffering from malabsorption, mainly Giardia infestation may develop iron deficiency resistent to further iron treatment. The purpose of this study is to assess the incidence of malabsorption in those infants and to examine the results of empiric treatment with metronidazole.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 months to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All infants referred to the Pediatric Hematology Unit because lack of response to iron treatment.
Key exclusion criteria (1 listed)
- Patients diagnosed with specific malabsorption causes like Celiac or Cystic Fibrosis.
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 |
|---|---|---|
| Metronidazole | Drug | – |
| Blood tests | Procedure or surgery | – |
Primary outcome
Hgb level
2 secondary outcomes
Iron level
Ferritin Level
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 5 Apr 2007.
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The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
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RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
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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.
Ariel Koren, MD study director
Pediatric Hematology Unit, Ha'Emek Medical Center
Carina Levin, MD principal investigator
Pediatric Hematology Unit - Ha'Emek Medical Center
Tania Hanchis, MD principal investigator
Pediatric Dpt B - Ha'Emek Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metronidazole and Blood tests in people with Iron Deficiency and Malabsorption, run by HaEmek Medical Center, Israel 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 1 inclusion and 1 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 5 Apr 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?
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?
Hgb level. 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 5 Apr 2007.