ClinicalTrials.gg
CompletedNCT03197233Updated Jun 26, 2017

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

An observational study in Asthma in Children, sponsored by Norwegian Institute of Public Health. Completed. Open to participants aged 7 Years to 7 Years. Per ClinicalTrials.gov, last updated 2017-06-26.

Sponsored by Norwegian Institute of Public Health · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
61,676
Ages
7 Years to 7 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Asthma in Children
03

In context

Lead sponsor

Norwegian Institute of Public Health is the lead sponsor of 51 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 7 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The Norwegian Mother and Child Study is a population-based pregnancy cohort (births 1999-2009). Women were recruited nationwide (41% participation) around 18 weeks gestation. The current study included 61,676 eligible chidren born 2002-2007.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
61,676 participants (actual)
Patient registry
No

Interventions

  • OtherMaternal vitamin A and D intake during pregnancy

    Dietary exposures during pregnancy and infant supplement use were assessed from maternal questionnaire report

    Also known as: Total vitamin A and D intake from food and supplements

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: A minimum of two dispensations around age 7 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Magnus P, Birke C, Vejrup K, Haugan A, Alsaker E, Daltveit AK, Handal M, Haugen M, Hoiseth 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. PubMed 27063603 ↗
  • Ronningen 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. doi: 10.1007/s10654-006-9041-x. Epub 2006 Sep 20. PubMed 17031521 ↗
  • Parr CL, Magnus MC, Karlstad O, Holvik K, Lund-Blix NA, Haugen M, Page CM, Nafstad P, Ueland PM, London SJ, Haberg SE, Nystad W. Vitamin A and D intake in pregnancy, infant supplementation, and asthma development: the Norwegian Mother and Child Cohort. Am J Clin Nutr. 2018 May 1;107(5):789-798. doi: 10.1093/ajcn/nqy016. PubMed 29722838 ↗

Individual participant data

Plan to share: Yes — Data have been shared with collaborators.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 1999 to primary completion in Jun 2015, 197 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 19, 2017
First posted
Jun 23, 2017
StartActual
Jan 1999
Primary completionActual
Jun 30, 2015
CompletionActual
Jun 30, 2015
Last update
Jun 26, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03197233
Lead sponsor
Norwegian Institute of Public Health
Responsible party
Sponsor
First posted
Jun 23, 2017
Start date
Jan 1999
Primary completion
Jun 30, 2015
Completion
Jun 30, 2015
Last update
Jun 26, 2017

Study contacts

Wenche Nystad, PhD
principal investigator · Dept of Non-Communicable Diseases, Norwegian Institute of Public Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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