Welcome
Support Centre
01 November 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
PACT: Prevention of Atopy among Children in Trondheim
ISRCTN ISRCTN28090297
DOI 10.1186/ISRCTN28090297
ClinicalTrials.gov identifier
EudraCT number
Public title PACT: Prevention of Atopy among Children in Trondheim
Scientific title A controlled, population-based intervention study for the Prevention of Atopy among Children in Trondheim
Acronym PACT
Serial number at source N/A
Study hypothesis The primary objective of the PACT trial is to study the efficacy of an intervention on three assumed risk factors for atopic disease (AD), asthma, and allergic rhinoconjunctivitis (ARC) in an unselected population of pregnant women and small children. Further, to study the effectiveness of intervening on these risk factors on the incidence of asthma and allergic disease.
1. Omega-3 fatty acid intake
2. Second hand smoke (SHS) exposure
3. Indoor “dampness”

The prospective structure and longevity of the PACT study enables etiological studies as well as prospective and nested case-cohort studies, and controlled clinical trials. Accordingly, three sub-studies, and an end-point study, were designed.

Publications under review (at time of registration)
1. Dotterud CK, Storro O, Johnsen R., Oien T. Probiotics in non-selected pregnant women in prevention of allergic disease: a randomised, double-blind, placebo-controlled trial. J Allergy Clin Immun. Under review June 2009.
2. Smidesang I, Saunes M, Storro O, Øien T, Holmen TL, Johnsen R. et al. Allergy related disorders among 2-year olds in a general population.The PACT study. Pediatric Allergy and Immunology. Under review June 2009.

Further reading:
2007 results of the Young-Hunt study on psychological morbidity in adolescents with atopic dermatitis in http://www.ncbi.nlm.nih.gov/pubmed/17223868
Lay summary Not provided at time of registration
Ethics approval 1. Approved by the Regional Committee for Research Ethics in Middle Norway,15/08/2000, ref: 120-2000
2. The Norwegian Data Inspectorate (ref: 2003/953-3 KBE/-) and the Probiotic study is registered in ClinicalTrials.gov (identifier NCT00159523)
Study design Prospective controlled population-based intervention study
Countries of recruitment Norway
Disease/condition/study domain Atopic and allergic diseases in early childhood; atopic eczema; allergic rhinoconjunctivitis; asthma
Participants - inclusion criteria All pregnant women living in the community of Trondheim, Norway willing to complete repeated questionnaires on risk factors and disease during pregnancy and until their child was 6 years of age could be included in the study
Participants - exclusion criteria Does not meet inclusion criteria
Anticipated start date 01/09/2000
Anticipated end date 31/12/2011
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 14000
Interventions 1. Increased omega-3- fatty acid intake in pregnancy and for children up to 2 years of age.
2. Reduced smoking behaviour and smoking cessation in pregnancy, reduced second hand smoke (SHS) exposure for mother and child after birth, smoking relapse prevention.
3. Reduced indoor “dampness” exposure

The interventions continue in all scheduled contacts with GPs, maternity care nurses and midwifes throughout the study period from early pregnancy until the child is 2 years of age. This schedule in incorporated as the recommended follow-up for all pregnant women in the community in the intervention period.

Brochures with information for participants were delivered at inclusion with updates at relevant contacts at 6 weeks postnatal, 1 year and 2 years after birth.
Primary outcome measure(s) Self-reported changes in risk factor exposure and behaviour reported in repeated questionnaires in pregnancy, 6 weeks postnatal an at 1 and 2 and 6 years after birth
Secondary outcome measure(s) Changes in prevalence of atopic disease when the child was 2 years of age and 6 years of age
Sources of funding 1. Norwegian Department of Health and Social affairs (Norway) - (1997-2003)
2. AstraZeneca Norge AS (Norway) - Control cohort funding (2000-2001)
3. Norwegian University of Science and Technology (Norges Teknisk-Naturvitenskapelige Universitet [NTNU]) (Norway) - Research fellow scholarship (1999-2003)
4. Norwegian Research Council (Norway) - Research fellow scholarship (1999-2003)
5. Norwegian Medical Association (Norwary) - Grant (1999)
6. SINTEF Unimed (Norway) - Grant (1999)
Trial website http://www.pact.no
Publications 1. Jenssen J., Storrø O., Øien T., Johnsen R. Prevention of allergy among children in Trondheim. Allergi i praksis 4, 34-38. 2001. [in Norwegian]
2. 2008 results on atopic dermatitis in 2-year olds in http://www.ncbi.nlm.nih.gov/pubmed/18304146
3. 2008 results on minimal smoking intervention for pregnant women and their partners in http://www.ncbi.nlm.nih.gov/pubmed/19666630
4. 2008 results on assessing atopic disease in 2-6 year olds in http://www.ncbi.nlm.nih.gov/pubmed/18345462
5. 2009 results on maternal smoking cessation during pregnancy and child weight in http://www.ncbi.nlm.nih.gov/pubmed/18602227
6. 2009 results on early intake of fish oils for prevention in http://www.ncbi.nlm.nih.gov/pubmed/19666630
7. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20667103
8. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21599876
9. 2012 allergy test substudy results in http://www.ncbi.nlm.nih.gov/pubmed/21960289
10. 2012 asthma results in http://www.ncbi.nlm.nih.gov/pubmed/23095804
11. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23394141
12. 2013 bifidobacteria results in http://www.ncbi.nlm.nih.gov/pubmed/23124244
Contact name Prof  Roar  Johnsen
  Address ISM, NTNU
  City/town Trondheim
  Zip/Postcode N-7489
  Country Norway
  Email roar.johnsen@ntnu.no
Sponsor Norwegian University of Science and Technology (Norway)
  Address Department of Community Medicine and general Practice
MTFS
  City/town Trondheim
  Zip/Postcode N-7489
  Country Norway
  Email ola.storro@ntnu.no
Date applied 01/12/2009
Last edited 13/11/2013
Date ISRCTN assigned 08/01/2010
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.