Celiac DiseaseNCT02036944
Celiac Disease and Unexplained Iron Deficiency in a Primary Care Setting
An observational study of Celiac Disease and Iron Deficiency, run by Providence Medical Research Center at 1 site in United States.
Trial summary
The purpose of this study is to determine if patients with unexplained iron deficiency have underlying diseases processes such as celiac disease. It is hypothesized that selectively screening patients with unexplained iron deficiency will reveal previously undiagnosed etiologies, including celiac disease and other… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Celiac Disease, Iron Deficiency, Iron Malabsorption
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Jan 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from Providence Internal Medicine Clinic, Providence Internal Medicine Residency Services and Providence Family Medicine Residency Services
Who may be able to join
- Active outpatients in the Providence Internal Medicine Residency Clinic, Family Medicine Residency Clinics, or Providence Internal Medicine Clinic
- Demographic Age > 18 years. Diagnostic criteria: markers of iron deficiency at last check are defined as MCV<80 fL, Iron Sat<20% or ferritin<30 ng/mL.
- Patient signs informed consent document and HIPAA authorization for release of personal health information.
- Ability to understand procedures and comply with them for one year duration of study
Who cannot join
- Any documented significant acute or chronic blood loss, per medical record review or self- report (see Appendix B). Significant blood loss includes
- Acute blood loss requiring iron treatment or transfusions within 1 year prior to the above measure of iron deficiency
- Chronic blood loss (such as menorrhagia, GI bleeding, hemoptysis, hematuria, chronic nose bleeds, hemolysis, regular blood donations, or major trauma requiring transfusion or iron therapy)
- Thalassemia or other major hemolytic diseases.
- Prior diagnosis of celiac disease, or other documented cause of iron malabsorption.
- Women who are currently pregnant, or who were pregnant with 6 months prior to time of last testing.
Show all 10Show fewer
- Those currently or recently on chemotherapy (within the last 6 months)
- Those with prior gastric resection or bariatric surgery
- Those with advanced chronic kidney disease (stage 4 or 5)
- Any other reasons that, in the investigators' opinion, may prevent compliance with protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence Medical Research Center
Spokane, Washington, 99204
About this study
The purpose of this study is to determine if patients with unexplained iron deficiency have underlying diseases processes such as celiac disease.
It is hypothesized that selectively screening patients with unexplained iron deficiency will reveal previously undiagnosed etiologies, including celiac disease and other causes of iron malabsorption along with various sources of occult GI blood loss.
Read the detailed description
The primary purpose of the study is to document unexplained iron deficiency and its relationship to celiac disease, iron malabsorption and occult intestinal blood loss. Test results given to primary care physicians may prompt further testing for celiac disease (duodenal biopsy) or other potential causes of occult iron deficiency. The specific endpoints to be evaluated include:
- Prevalence of specific serum markers of celiac disease in those with unexplained serum markers of iron deficiency.
- Prevalence of iron malabsorption with and without celiac disease in the same population
- Frequency of other blood tests for malabsorption and their association with celiac disease or other cause of iron malabsorption.
- Frequency of specific historical markers associated with celiac disease
- Prevalence of unrecognized GI blood loss
- Quality of life improvement based on new diagnoses with appropriate therapy
- After one year follow-up, review patient records for additional diagnoses explaining iron deficiency.
Primary Objective:
Discover several etiologies of unexplained iron deficiency in a primary care clinic population including celiac disease, iron malabsorption and occult intestinal blood loss.
Secondary Objectives:
- Define percent of total clinic patient population with one or more markers of iron deficiency on last testing and the subset without an apparent etiology on their problem list ("study group").
- Define percent of patients in the study group that are currently iron deficient at time of study onset, and how many of those are actually anemic.
- Define percent of study group patients with iron malabsorption, with or without celiac disease.
- Document improved quality of life outcomes for those with new diagnoses and appropriate therapy, including celiac disease given gluten-free diet and iron therapy.
- For those patients identified with celiac disease, do statistical analysis of historical and lab parameters that are more highly linked to celiac disease to improve screening parameters.
- Document percent of various diagnoses that explain occult iron deficiency as found by primary care providers over the course of a one year follow-up after initial diagnosis. (Providers will be given all testing results related to their patients after the initial screening and at one year.)
- Specific cost-effectiveness of this screening procedure may be done in a future study if preliminary results are suggestive of improved outcomes.
- Conditions
- Celiac Disease, Iron Deficiency, Iron Malabsorption
- Keywords
- Celiac Disease, Celiac Sprue, Iron-Deficiency Anemia
- Medical subject headings
- Celiac Disease, Iron Deficiencies, Anemia, Iron-Deficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive results for Expanded Celiac Disease Panel
Expanded Celiac Disease Panel includes TTG-IgG, TTG-IgA, AntiGliadin-IgG, AngtiGliadin-IgA, and Total Serum IgA
Measured: Upon consent and enrollment in the study, laboratory tests will be done to evaluate for the presence of Celiac Disease
Secondary outcomes (1)
Percentage of Clinic Patient Population with one or more markers of iron deficiency
Other tests will be done at enrollment to assess for iron malabsorption and possibly to identify causes of iron malabsorption other than celiac disease. These include Iron absorption Testing (serum iron level before and after oral FeSO4 tablet or liquid), with percent iron saturation. Ferritin, Hemoglobin and Hematocrit, Vitamin D level, Folate, Vitamin B12 level, Aspartate Aminotransferase (AST), and Stool Occult Blood Test
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startMar 2014
- Primary completionJan 2015
- Study completionJan 2015
Why it stopped: Study stopped d/t lack of enrollment and no compelling data.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies 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
- Cohort
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence Medical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Providence Sacred Heart Medical Center & Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Samuel Palpant, MD, Principal investigator, Providence Internal Medicine Residency Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036944
- Sponsor's protocol ID
- PMRC-1909-1
- Status last verified
- Apr 2016
- First submitted
- 13 Jan 2014
- Last updated
- 5 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Celiac Disease and Unexplained Iron Deficiency in a Primary Care Setting
- ClinicalTrials.gov ID
- NCT02036944
- Acronym / sponsor ID
- PMRC-1909-1
- Conditions
- Celiac Disease, Iron Deficiency, Iron Malabsorption
- Keywords
- Celiac Disease, Celiac Sprue, Iron-Deficiency Anemia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study stopped d/t lack of enrollment and no compelling data.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Providence Medical Research CenterUniversity, hospital or other
- Collaborators
- Providence Sacred Heart Medical Center & Children's Hospital
- Study start
- Mar 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 15 Jan 2014 (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 purpose of this study is to determine if patients with unexplained iron deficiency have underlying diseases processes such as celiac disease.
It is hypothesized that selectively screening patients with unexplained iron deficiency will reveal previously undiagnosed etiologies, including celiac disease and other causes of iron malabsorption along with various sources of occult GI blood loss.
Detailed description
The primary purpose of the study is to document unexplained iron deficiency and its relationship to celiac disease, iron malabsorption and occult intestinal blood loss. Test results given to primary care physicians may prompt further testing for celiac disease (duodenal biopsy) or other potential causes of occult iron deficiency. The specific endpoints to be evaluated include:
- Prevalence of specific serum markers of celiac disease in those with unexplained serum markers of iron deficiency.
- Prevalence of iron malabsorption with and without celiac disease in the same population
- Frequency of other blood tests for malabsorption and their association with celiac disease or other cause of iron malabsorption.
- Frequency of specific historical markers associated with celiac disease
- Prevalence of unrecognized GI blood loss
- Quality of life improvement based on new diagnoses with appropriate therapy
- After one year follow-up, review patient records for additional diagnoses explaining iron deficiency.
Primary Objective:
Discover several etiologies of unexplained iron deficiency in a primary care clinic population including celiac disease, iron malabsorption and occult intestinal blood loss.
Secondary Objectives:
- Define percent of total clinic patient population with one or more markers of iron deficiency on last testing and the subset without an apparent etiology on their problem list ("study group").
- Define percent of patients in the study group that are currently iron deficient at time of study onset, and how many of those are actually anemic.
- Define percent of study group patients with iron malabsorption, with or without celiac disease.
- Document improved quality of life outcomes for those with new diagnoses and appropriate therapy, including celiac disease given gluten-free diet and iron therapy.
- For those patients identified with celiac disease, do statistical analysis of historical and lab parameters that are more highly linked to celiac disease to improve screening parameters.
- Document percent of various diagnoses that explain occult iron deficiency as found by primary care providers over the course of a one year follow-up after initial diagnosis. (Providers will be given all testing results related to their patients after the initial screening and at one year.)
- Specific cost-effectiveness of this screening procedure may be done in a future study if preliminary results are suggestive of improved outcomes.
Study design
- Observational model
- Cohort
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from Providence Internal Medicine Clinic, Providence Internal Medicine Residency Services and Providence Family Medicine Residency Services
Key inclusion criteria (4 listed)
- Active outpatients in the Providence Internal Medicine Residency Clinic, Family Medicine Residency Clinics, or Providence Internal Medicine Clinic
- Demographic Age > 18 years. Diagnostic criteria: markers of iron deficiency at last check are defined as MCV<80 fL, Iron Sat<20% or ferritin<30 ng/mL.
- Patient signs informed consent document and HIPAA authorization for release of personal health information.
- Ability to understand procedures and comply with them for one year duration of study
Key exclusion criteria (10 listed)
- Any documented significant acute or chronic blood loss, per medical record review or self- report (see Appendix B). Significant blood loss includes
- Prior diagnosis of celiac disease, or other documented cause of iron malabsorption.
- Women who are currently pregnant, or who were pregnant with 6 months prior to time of last testing.
- Those currently or recently on chemotherapy (within the last 6 months)
- Those with prior gastric resection or bariatric surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Positive results for Expanded Celiac Disease Panel
Time frame: Upon consent and enrollment in the study, laboratory tests will be done to evaluate for the presence of Celiac Disease
Expanded Celiac Disease Panel includes TTG-IgG, TTG-IgA, AntiGliadin-IgG, AngtiGliadin-IgA, and Total Serum IgA
1 secondary outcome
Percentage of Clinic Patient Population with one or more markers of iron deficiency
Time frame: at enrollment
Results and safety
The study was stopped early (reason given: Study stopped d/t lack of enrollment and no compelling data.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2016.
- Individual participant dataSharing planned: No
Related trials for Celiac Disease
Active, not recruitingEarly Phase 1
VTP-1000 in Adults With Celiac Disease
Celiac Disease
RecruitingObservational study
Impact of Mediterranean Diet and Processed Food Consumption on Gastrointestinal Symptoms in Coeliac Patients on a Gluten-Free Diet
Celiac Disease, Gluten-free Diet
Recruiting
GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health)
Celiac Disease in Children, Nutrition Disorder, Child
RecruitingObservational study
Celiac Disease Genomic Environmental Microbiome and Metabolomic Study
Celiac Disease
RecruitingObservational study
Pathogenic Study of Adult Immune Enteropathies
Celiac Disease, Autoimmune Enteropathy
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.
Samuel Palpant, MD principal investigator
Providence Internal Medicine Residency Services
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 Celiac Disease and Iron Deficiency, run by Providence Medical Research Center 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 4 inclusion and 10 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: stopped early, as of the sponsor's last update on 5 Apr 2016. 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.
Are results available for this study?
The study was stopped early (reason given: Study stopped d/t lack of enrollment and no compelling data.). Results are not available in the source record.
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?
Positive results for Expanded Celiac Disease Panel (time frame: Upon consent and enrollment in the study, laboratory tests will be done to evaluate for the presence of Celiac Disease). 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 2016.