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NCT00778258 · ClinicalTrials.gov registry record · Phase 2
Study of Milk Allergy and Tolerance in Children
A Phase 2 study of Food Hypersensitivity and Milk Hypersensitivity, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 170
- Enrollment target
- 1
- Study location
NCT00778258: Completed Phase 2 study of Food Hypersensitivity and Milk Hypersensitivity, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00778258 is a Phase 2 study of Food Hypersensitivity and Milk Hypersensitivity that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 170 participants, below the 4,629-participant average among 5 other Food Hypersensitivity trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00778258, a Phase 2 study of Food Hypersensitivity and Milk Hypersensitivity, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 170 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine if children who are allergic to milk can increase tolerance through frequent dose-escalation every 6 months versus 12 months leading to eventual tolerance of less heated milk and ultimately unheated milk.
Primary Outcome
Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1=reacted to muffin; Group 2=reacted to pizza; Group 3=reacted to rice pudding; Group 4=reacted to non-baked milk; Group 5=did not react. Groups 2, 3, and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Par
Conditions Studied
Interventions
- BIOLOGICAL Baked Milk
- BIOLOGICAL Non-baked Milk
Study Locations (1)
New York
- Mount Sinai School of Medicine - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 170 participants |
| Start Date | 2008-08 |
| Est. Completion | 2014-11 |
| Phase | Phase 2 |
What the finished NCT00778258 record still lists
NCT00778258 is an interventional study that assigns participants to a tested intervention. The registered 170 participants enrollment target is mid-sized for trials with a published cap, below the 4,629-participant average among 5 other Food Hypersensitivity trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Food Hypersensitivity appearing as the primary indexed condition, and to 2 interventions - of which Baked Milk is the first listed.
NCT00778258 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT00778258 about?
NCT00778258 is a clinical study titled "Study of Milk Allergy and Tolerance in Children". The purpose of this study is to determine if children who are allergic to milk can increase tolerance through frequent dose-escalation every 6 months versus 12 months leading to eventual tolerance of less heated milk and ultimately unheated milk.
What is the current status of trial NCT00778258?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 170 participants. The study started on 2008-08. Estimated completion is 2014-11.
What conditions does trial NCT00778258 study?
This clinical trial studies the following conditions: Food Hypersensitivity, Milk Hypersensitivity.
What interventions are being tested in trial NCT00778258?
The interventions under investigation include: Baked Milk (BIOLOGICAL), Non-baked Milk (BIOLOGICAL).
Who is sponsoring clinical trial NCT00778258?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00778258 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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