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NCT01546753 · ClinicalTrials.gov registry record · Phase 1
Walnut Oral Immunotherapy for Tree Nut Allergy
A Phase 1 study, sponsored by University of Arkansas.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT01546753: Completed Phase 1 study, sponsored by University of Arkansas.
NCT01546753 is a Phase 1 study that has completed, run by University of Arkansas. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01546753, a Phase 1 study, has completed, sponsored by University of Arkansas.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if walnut oral immunotherapy can be used in participants allergic to tree nuts to reduce tree nut allergy and induce changes in the participant's immune system.
Primary Outcome
Determine in tree nut allergic subjects the effectiveness of walnut oral immunotherapy on clinical desensitization to a second tree nut ("test tree nut") causing allergy when compared to placebo treatment, as measured by the change in cumulative dose from baseline oral food challenge (OFC) to the OFC to the test tree nut at approximately 38 weeks on therapy.
Interventions
- DRUG Walnut Protein Powder
- DRUG Oat Powder (placebo)
- DRUG Open-label Walnut Protein Powder
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2012-04-27 |
| Est. Completion | 2020-07-02 |
| Phase | Phase 1 |
What the finished NCT01546753 record still lists
NCT01546753 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 3 interventions - of which Walnut Protein Powder is the first listed.
NCT01546753 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01546753 about?
NCT01546753 is a clinical study titled "Walnut Oral Immunotherapy for Tree Nut Allergy". The purpose of this study is to determine if walnut oral immunotherapy can be used in participants allergic to tree nuts to reduce tree nut allergy and induce changes in the participant's immune system.
What is the current status of trial NCT01546753?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2012-04-27. Estimated completion is 2020-07-02.
What interventions are being tested in trial NCT01546753?
The interventions under investigation include: Walnut Protein Powder (DRUG), Oat Powder (placebo) (DRUG), Open-label Walnut Protein Powder (DRUG).
Who is sponsoring clinical trial NCT01546753?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01546753's enrollment target sits among peer trials
22 1601st of 2000 higher than 386 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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