Vitamin A and D Intake in Pregnancy, Infant Supplementation and Asthma Development

Asthma in Children Clinical Trial

Official title:

Norwegian Mother and Child Study - Causal Pathways for Asthma (CASPAR)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03197233
• Other study ID #: PDB532_journal 08/2602-29
• Secondary ID: 221097ZO1ES49019
• Status: Completed
• Phase: N/A
• First received: June 19, 2017
• Last updated: June 23, 2017
• Start date: January 1999
• Est. completion date: June 30, 2015

Study information

• Verified date: June 2017
• Source: Norwegian Institute of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this study is to investigate if maternal intake of vitamins A and D from food and dietary supplements during pregnancy, and infant supplementation with these vitamins, are associated with development of asthma in the offspring.

Description:

This study was conducted as part of the research project "Causal pathways for asthma" funded by the Norwegian Research Council (2013-2017). The overall objective was to study if different pregnancy and early life exposures affect the risk of asthma and allergic diseases in children, and if these exposures exert their effects through epigenetic mechanisms, more specifically DNA methylation.

For this project, including the current study, existing data from the Norwegian Mother and Child Study (MoBa file version 9, 115 398 children and 95 248 mothers) were linked with the Medical Birth Registry of Norway and the Norwegian Prescription Database. The MoBa study recruited pregnant women between 1999 and 2008, at approximately 18 weeks of gestation. Beginning 2002, women completed a food frequency questionnaire about dietary intake (food and supplements) in pregnancy. A panel of maternal plasma biomarkers, including plasma retinol and 25-hydroxyvitamin D2 and D3, was available for a random sample of around 3,000 women who gave birth in 2002 and 2003.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61676
• Est. completion date: June 30, 2015
• Est. primary completion date: June 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 7 Years

Eligibility

Inclusion Criteria:

Available maternal dietary intake data from pregnancy. Child turned 7 years by July 1st 2014.

Exclusion Criteria:

No maternal baseline questionnaire. Maternal energy intake <4,500 or > 20,000 kJ. No dietary supplement data. No linkage to national birth registry, or non-live births, or multiple births. Child death, or emigration, or unknown vital status.

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

Other:
• Maternal vitamin A and D intake during pregnancy
Dietary exposures during pregnancy and infant supplement use were assessed from maternal questionnaire report

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian Institute of Public Health	National Institute of Environmental Health Sciences (NIEHS)

References & Publications (2)

Magnus P, Birke C, Vejrup K, Haugan A, Alsaker E, Daltveit AK, Handal M, Haugen M, Høiseth G, Knudsen GP, Paltiel L, Schreuder P, Tambs K, Vold L, Stoltenberg C. Cohort Profile Update: The Norwegian Mother and Child Cohort Study (MoBa). Int J Epidemiol. 2016 Apr;45(2):382-8. doi: 10.1093/ije/dyw029. Epub 2016 Apr 10. — View Citation

Rønningen KS, Paltiel L, Meltzer HM, Nordhagen R, Lie KK, Hovengen R, Haugen M, Nystad W, Magnus P, Hoppin JA. The biobank of the Norwegian Mother and Child Cohort Study: a resource for the next 100 years. Eur J Epidemiol. 2006;21(8):619-25. Epub 2006 Sep 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child asthma based on dispensed asthma medications	Dispensations of antiasthmatics (Anatomical Therapeutic Chemical Classification/ATC codes R03AC, R03BA, R03AK, and R03DC) registered in the Norwegian Prescription Database	A minimum of two dispensations around age 7 years

External Links

•   MoBa study protocol