NCT01361347

Brief Summary

The purpose of this study is to study the number of Participants with Adverse Events as a Measure of Safety and Tolerability.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2011

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 26, 2011

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 4, 2017

Status Verified

January 1, 2017

Enrollment Period

8.8 years

First QC Date

February 24, 2011

Last Update Submit

January 2, 2017

Conditions

Milk AllergyAnaphylaxis

Keywords

milk allergydesensitizationanaphylaxisschool-age

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events as a measure of safety and tolerability

    12 months

Secondary Outcomes (1)

  • Number of participants drinking 2 dl/day of milk (success in desensitization)

    12 months

Study Arms (2)

placebo

PLACEBO COMPARATOR

rice/soy/oat "milk"drink, masked

Dietary Supplement: milk

milk

EXPERIMENTAL

cow's milk

Dietary Supplement: milk

Interventions

milkDIETARY_SUPPLEMENT

milk for milk allergic children (1:25 dilution, whole milk)

Also known as: milk allergy, desensitization
milkplacebo

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • IgE-mediated milk allergy

You may not qualify if:

  • Not willing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital, Allergy Centre

Tampere, FIN-33521, Finland

Location

MeSH Terms

Conditions

Milk HypersensitivityAnaphylaxis

Interventions

MilkDesensitization, Psychologic

Condition Hierarchy (Ancestors)

Food HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and BeveragesBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Marita Paassilta, MD, PhD

    Consultant Pediatric Allergist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Paediatric Allergist

Study Record Dates

First Submitted

February 24, 2011

First Posted

May 26, 2011

Study Start

February 1, 2008

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 4, 2017

Record last verified: 2017-01

Locations

FI(1)