NCT03197233

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61,676

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1999

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1999

Completed
16.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2015

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 23, 2017

Completed
Last Updated

June 26, 2017

Status Verified

June 1, 2017

Enrollment Period

16.5 years

First QC Date

June 19, 2017

Last Update Submit

June 23, 2017

Conditions

Outcome Measures

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

    A minimum of two dispensations around age 7 years

Interventions

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

Eligibility Criteria

Age7 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 27063603BACKGROUND
  • 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.

    PMID: 17031521BACKGROUND
  • 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.

Study Officials

  • Wenche Nystad, PhD

    Dept of Non-Communicable Diseases, Norwegian Institute of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2017

First Posted

June 23, 2017

Study Start

January 1, 1999

Primary Completion

June 30, 2015

Study Completion

June 30, 2015

Last Updated

June 26, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will share

Data have been shared with collaborators.