|
Welcome
|
|
18 May 2013
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | news |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ 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 on the 15th of August 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 |
| Contact name | Prof Roar Johnsen |
| Address | ISM, NTNU |
| City/town | Trondheim |
| Zip/Postcode | N-7489 |
| Country | Norway |
| 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 |
| ola.storro@ntnu.no | |
| Date applied | 01/12/2009 |
| Last edited | 17/05/2013 |
| Date ISRCTN assigned | 08/01/2010 |
|
|
|
|
|
| © 2013 ISRCTN unless otherwise stated. | |
|
