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

June 23, 2017 updated by: Norwegian Institute of Public Health

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

61676

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 7 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child asthma based on dispensed asthma medications
Time Frame: A minimum of two dispensations around age 7 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian Institute of Public Health

Collaborators

National Institute of Environmental Health Sciences (NIEHS)

Investigators

  • Principal Investigator: Wenche Nystad, PhD, Dept of Non-Communicable Diseases, Norwegian Institute of Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 1999

Primary Completion (ACTUAL)

June 30, 2015

Study Completion (ACTUAL)

June 30, 2015

Study Registration Dates

First Submitted

June 19, 2017

First Submitted That Met QC Criteria

June 22, 2017

First Posted (ACTUAL)

June 23, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 26, 2017

Last Update Submitted That Met QC Criteria

June 23, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDB532_journal 08/2602-29
  • 221097 (Norwegian Research Council/BIOBANK program)
  • ZO1ES49019 (OTHER_GRANT: National Institute of Environmental Health Sciences)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data have been shared with collaborators.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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