Condition category
Nutritional, Metabolic, Endocrine
Date applied
26/09/2005
Date assigned
26/09/2005
Last edited
11/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.TRIGR.org

Contact information

Type

Scientific

Primary contact

Dr John Dupre

ORCID ID

Contact details

John P. Robarts Research Institute
PO Box 5015
100 Perth Dr.
London
N6A 5K8
Canada
+1 519 663 2935
john.dupre@lhsc.on.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00179777

Protocol/serial number

MCT-49395

Study information

Scientific title

Trial to Reduce Insulin dependent diabetes mellitus in the Genetically at Risk: a randomised controlled trial

Acronym

TRIGR

Study hypothesis

The hypothesis for this proposal holds that weaning to an extensively hydrolysed infant formula will decrease the incidence of type I diabetes, as it does in all relevant animal models for the disease.

Ethics approval

1. The Hospital District of Helsinki and UUSIMAA, Finland, 19/09/2000
2. The Ethical Committee of Paediatrics and Psychiatry, London Health Sciences Centre, London, Ontario, 02/05/2002

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Patient information can be found at: http://www.TRIGRNorthAmerica.org

Condition

Type 1 Diabetes Mellitus

Intervention

Experimental Arm:
Use of infant feed formula, cow milk based, extensively hydrolysed administered when needed in supplementation or substitution for breast milk through 6 - 8 months from birth. (Formulated by MeadJohnson)

Control Arm:
Use of infant feed formula, cow milk based, non-hydrolysed administered when needed in supplementation or substitution for breast milk through 6 - 8 months from birth. (Formulated by MeadJohnson)

Trial details received: 12 Sept 2005

Intervention type

Drug

Phase

Not Applicable

Drug names

Infant feed formulas

Primary outcome measures

Development of diabetes mellitus

Secondary outcome measures

1. Development of diabetes associated islet antibodies ICA, IAA, GADA Abs, IA-2A Abs
2. Development of cow milk protein antibodies

Overall trial start date

01/03/2002

Overall trial end date

31/05/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. The biological parents and/or full (not half) sibling of the newborn infant has type 1 diabetes as defined by the World Health Organization
2. The infant’s parents or legal guardians give signed consent to participate

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

2730

Participant exclusion criteria

1. An older sibling of the newborn infant has been included in the TRIGR intervention
2. Multiple gestation
3. The parents are unwilling or unable to feed the infant cow’s milk based products for any reason (e.g. religious, cultural)
4. The newborn infant has a recognisable severe illness such as those due to chromosomal abnormality, congenital malformation, respiratory failure needing assisted ventilation, enzyme deficiencies etc.
5. The gestational age of the newborn infant is less than 35 weeks
6. The infant is older than 7 days at randomisation
7. Inability of the family to take part in the study (e.g. the family has no access to any of the Study Centres, the family has no telephone)
8. The infant has received any infant formula other than Nutramigen prior to randomisation
9. No HLA sample drawn before the age of 8 days

Recruitment start date

01/03/2002

Recruitment end date

31/05/2016

Locations

Countries of recruitment

Australia, Canada, Czech Republic, Estonia, Finland, Germany, Hungary, Italy, Luxembourg, Netherlands, Poland, Spain, Sweden, Switzerland, United States of America

Trial participating centre

John P. Robarts Research Institute
London
N6A 5K8
Canada

Sponsor information

Organisation

John P. Robarts Research Institute (Canada)

Sponsor details

University of Helsinki
University of Pittsburgh
University of South Florida – U.S. NIH funds
for John Robarts Research Institute
P.O. Box 5015
100 Perth Drive
London
N6A 5K8
Canada

Sponsor type

Not defined

Website

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada), ref: MCT-49395

Alternative name(s)

Instituts de Recherche en Santé du Canada, CIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Canada

Funder name

US Congress (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Institute of Child health and Human Development (NICHD) (USA)

Alternative name(s)

NICHD

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

United States of America

Funder name

Juvenile Diabetes Research Foundation (JDRF) (Direct) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

European Foundation for the Study of Diabetes (EFSD)/JDRF/Novo Nordisk

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Finnish Diabetes Research Foundation (Finland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Academy of Finland (Finland)

Alternative name(s)

Academy of Finland

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

Finland

Funder name

Dutch Diabetes Research Foundation (Netherlands)

Alternative name(s)

Dutch Diabetes Research Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Netherlands

Funder name

European Union (EU)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2007 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17550422
2013 recruitment and retention strategies in: http://www.ncbi.nlm.nih.gov/pubmed/24216218

Publication citations

  1. Protocol

    Study design of the Trial to Reduce IDDM in the Genetically at Risk (TRIGR)., Pediatr Diabetes, 2007, 8, 3, 117-137, doi: 10.1111/j.1399-5448.2007.00239.x.

  2. Recruitment and retention strategies

    Franciscus M, Nucci A, Bradley B, Suomalainen H, Greenberg E, Laforte D, Kleemola P, Hyytinen M, Salonen M, Martin MJ, Catte D, Catteau J, , Recruitment and retention of participants for an international type 1 diabetes prevention trial: a coordinators' perspective., Clin Trials, 2014, 11, 2, 150-158, doi: 10.1177/1740774513510070.

Additional files

Editorial Notes