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NCT01927276 · ClinicalTrials.gov registry record · NA
Randomized Controlled Trial of a Gluten Free Diet In Patients With Schizophrenia Who Are Gliadin-Positive
A NA study, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- NA
- Development phase
- 26
- Enrollment target
NCT01927276 is a NA study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 26 participants.
The verdict
NCT01927276, a NA study, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- NA
- Development phase
- 26 participants
- Enrollment target
Study Summary
Out of 300 million persons in the United States, about one-half of one percent, or 1.5 million, have a diagnosis of schizophrenia. Schizophrenia begins in young adulthood, and often is chronic and disabling for the remainder of the life course\], which is shorter than for the general population by as much as 25 years. The costs of schizophrenia in the United States are estimated to be between $30 and $60 billion dollars annually. Treatment for schizophrenia is only marginally successful: in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE), for example, the medication prescribed at the beginning of the trial was stopped or changed in nearly 75% by the completion of the trial 18 months later. The medications have limited effect on negative symptoms or cognitive impairments of schizophrenia, and many have severe and permanent side effects. The basic hypothesis underlying treatment for schizophrenia has not changed for more than half a century. New treatments are needed. Much accumulating evidence suggests that sensitivity to gluten may be related to symptoms or etiology in schizophrenia and that gluten free diets may lead to significant symptom resolution, but only in patients who are known to have antibodies to gluten. Gluten sensitivity may be more common than thought and stems from a different etiology and symptom presentation than Celiac Disease. The investigators analysis of the CATIE sample show that about 23% of persons with schizophrenia (compared to 3% of healthy controls) have Gluten Sensitivity (about 300,000 persons in the United States) through the identification of gliadin positive antibodies in their blood. The investigators hypothesize that people with this biomarker could have robust symptom improvements with the removal of the antigen from the diet (gluten). If only half of people with schizophrenia and these antibodies were to substantially benefit from removal of gluten from the diet, as in the case studies and with certain
Interventions
- OTHER Gluten Free Flour
- OTHER Wheat Flour
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2013-09-01 |
| Est. Completion | 2017-05-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01927276
The ClinicalTrials.gov registry entry for NCT01927276 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Gluten Free Flour is the first listed.
NCT01927276 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01927276 about?
NCT01927276 is a clinical study titled "Randomized Controlled Trial of a Gluten Free Diet In Patients With Schizophrenia Who Are Gliadin-Positive". Out of 300 million persons in the United States, about one-half of one percent, or 1.5 million, have a diagnosis of schizophrenia. Schizophrenia begins in young adulthood, and often is chronic and disabling for the remainder of the life course\], which is shorter than for the general population by a...
What is the current status of trial NCT01927276?
This trial is currently completed. It is a NA study. The enrollment target is 26 participants. The study started on 2013-09-01. Estimated completion is 2017-05-01.
What interventions are being tested in trial NCT01927276?
The interventions under investigation include: Gluten Free Flour (OTHER), Wheat Flour (OTHER).
Who is sponsoring clinical trial NCT01927276?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
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