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A Randomized, Double-Blind, Placebo-Controlled Study of Oral Milk Immunotherapy for Cow's Milk Allergy

This study has been completed.
Sponsor:
Collaborator:
Duke University
Information provided by (Responsible Party):
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00465569
First received: April 23, 2007
Last updated: April 18, 2017
Last verified: April 2017
Results First Received: February 17, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Condition: Milk Hypersensitivity
Interventions: Drug: cow's milk powder
Other: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Children between the ages of 6 and 21 years with a known history of IgE-mediated milk allergy were recruited from the pediatric allergy clinics at the Johns Hopkins University Hospital, Baltimore, Maryland, and Duke University Medical Center, Durham, North Carolina.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligibility criteria were a positive skin prick test (SPT) response to milk extract (wheal ≥ histamine control) or milk immunoglobulin E (IgE) level of > 0.35 kilounits per liter (kU/L) and a positive milk challenge result at baseline defined as reacting with clear signs, symptoms, or both to a cumulative dose of 2.5 g or less of milk protein.

Reporting Groups
  Description
Active Treatment

Pre-measured doses of dry, nonfat powered milk prepared by the clinical research-registered dieticians

cow's milk powder: Milk powder given orally in escalating doses to a goal of 500 mg for approximately 23 weeks

Placebo Pre-measured doses of ProFree, a dry, milk free powder

Participant Flow:   Overall Study
    Active Treatment   Placebo
STARTED   13   7 
COMPLETED   12   7 
NOT COMPLETED   1   0 
persistent eczema during dose escalation                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Active Treatment

Pre-measured doses of dry, nonfat powered milk prepared by the clinical research-registered dieticians

cow's milk powder: Milk powder given orally in escalating doses to a goal of 500 mg for approximately 23 weeks

Placebo Placebo
Total Total of all reporting groups

Baseline Measures
   Active Treatment   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 13   7   20 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      13 100.0%      7 100.0%      20 100.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 9.3  (3.3)   10.2  (3.3)   9.5  (2.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      5  38.5%      3  42.9%      8  40.0% 
Male      8  61.5%      4  57.1%      12  60.0% 
Region of Enrollment 
[Units: Participants]
     
United States   13   7   20 
History of eczema 
[Units: Participants]
Count of Participants
 7   4   11 
Current eczema 
[Units: Participants]
Count of Participants
 4   2   6 
History of asthma 
[Units: Participants]
Count of Participants
 12   5   17 
Current asthma 
[Units: Participants]
Count of Participants
 9   3   12 
History of other food allergy 
[Units: Participants]
Count of Participants
 10   5   15 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Median Milk Threshold Dose Inducing a Reaction   [ Time Frame: Baseline and 23 weeks ]

2.  Secondary:   Changes in Cow Milk-IgE   [ Time Frame: Baseline and 23 weeks ]

3.  Secondary:   Changes in Cow Milk Immunoglobulin G4 (IgG4)   [ Time Frame: Baseline and 23 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Robert A. Wood, MD
Organization: Johns Hopkins University
phone: 410-955-5883
e-mail: rwood@jhmi.edu


Publications of Results:
Other Publications:

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00465569     History of Changes
Other Study ID Numbers: NA_00002102
Study First Received: April 23, 2007
Results First Received: February 17, 2017
Last Updated: April 18, 2017