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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00179777




Registration number
NCT00179777
Ethics application status
Date submitted
10/09/2005
Date registered
16/09/2005

Titles & IDs
Public title
TRIGR - Primary Prevention Study for Type 1 Diabetes in Children at Risk
Scientific title
TRIGR - Trial to Reduce IDDM in the Genetically at Risk
Secondary ID [1] 0 0
U01HD040364
Secondary ID [2] 0 0
MCT-49395
Universal Trial Number (UTN)
Trial acronym
TRIGR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 1 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Hydrolysed infant formula
Treatment: Other - Nonhydrolysed infant formula

Experimental: Hydrolysed infant formula - Hydrolysed infant formula

Placebo comparator: Nonhydrolysed infant formula - Nonhydrolysed cow's milk based infant formula


Treatment: Other: Hydrolysed infant formula
Participants in the Hydrolysed infant formula -group received the test formula, casein hydrolysate (Nutramigen™, Mead Johnson Nutritionals), not containing antigenic CM protein, whenever breast milk is not available.

Treatment: Other: Nonhydrolysed infant formula
Participants in the Nonydrolysed infant formula -group received the CM protein containing control formula which has an addition (20 %) of Nutramigen, whenever breast milk is not available.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Type 1 Diabetes Mellitus
Timepoint [1] 0 0
12 and 18 months and annually from 2 years up to 14 years
Secondary outcome [1] 0 0
Number of Participants With Diabetes Associated Autoantibodies
Timepoint [1] 0 0
3, 6, 9, 12, 18 months and annually from 2 years up to 14 years

Eligibility
Key inclusion criteria
* Biological parent and/or full (not half) sibling of the newborn infant had type 1 diabetes as defined by the World Health Organization
* The infant's parent or legal guardians gave signed consent to participate
Minimum age
No limit
Maximum age
7 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* An older sibling of the newborn infant had been included in the TRIGR intervention
* Multiple gestation
* The parents were unwilling or unable to feed the infant cow's milk based products for any reason (e.g., religious, cultural).
* The newborn infant had a recognizable severe illness such as those due to chromosomal abnormality, congenital malformation, respiratory failure needing assisted ventilation, enzyme deficiencies, etc.
* The gestational age of the newborn infant was less than 35 weeks.
* The infant was older than 7 days at randomization.
* Inability of the family to take part in the study (e.g. the family has no access to any of the Study Centers, the family has no telephone).
* The infant had received any infant formula other than Nutramigen prior to randomization.
* No HLA sample drawn before the age of 8 days.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/05/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/09/2017
Sample size
Target
Accrual to date
Final
5156
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Pennsylvania
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
Czechia
State/province [4] 0 0
Prague
Country [5] 0 0
Estonia
State/province [5] 0 0
Tartu
Country [6] 0 0
Finland
State/province [6] 0 0
Helsinki
Country [7] 0 0
Germany
State/province [7] 0 0
Hannover
Country [8] 0 0
Hungary
State/province [8] 0 0
Budapest
Country [9] 0 0
Italy
State/province [9] 0 0
Sardinia
Country [10] 0 0
Italy
State/province [10] 0 0
Rome
Country [11] 0 0
Luxembourg
State/province [11] 0 0
Luxembourg
Country [12] 0 0
Netherlands
State/province [12] 0 0
Rotterdam
Country [13] 0 0
Poland
State/province [13] 0 0
Wroclaw
Country [14] 0 0
Spain
State/province [14] 0 0
Vizcaya
Country [15] 0 0
Spain
State/province [15] 0 0
Madrid
Country [16] 0 0
Sweden
State/province [16] 0 0
Linkoping
Country [17] 0 0
Switzerland
State/province [17] 0 0
Zurich

Funding & Sponsors
Primary sponsor type
Other
Name
University of Helsinki
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
US Congress
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Government body
Name [3] 0 0
Canadian Institutes of Health Research (CIHR)
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Juvenile Diabetes Research Foundation
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
European Community (EC)
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
European Foundation for the Study of Diabetes
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Commercial sector/industry
Name [7] 0 0
Mead Johnson Nutrition
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Academy of Finland
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
Diabetes Research Foundation, Finland
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
Dutch Diabetes Research Foundation
Address [10] 0 0
Country [10] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mikael Knip, MD
Address 0 0
University of Helsinki
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

TypeCitations or Other Details
Journal Writing Group for the TRIGR Study Group; Knip M, A... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT00179777