NCT03273725

Brief Summary

The main aim of this study is to investigate potential associations between maternal pre- and postnatal vitamin D level and oral health outcomes (caries and developmental defects of enamel) in their children at 7-9 years of age.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
178

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2016

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

First Submitted

Initial submission to the registry

January 24, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 6, 2017

Completed
Last Updated

September 6, 2017

Status Verified

September 1, 2017

Enrollment Period

1.2 years

First QC Date

January 24, 2016

Last Update Submit

September 1, 2017

Conditions

Keywords

Oral HealthVitamin D

Outcome Measures

Primary Outcomes (1)

  • Dental caries in the primary teeth of the children at the age of 7-9 yrs

    The main study was conducted in 2007 - 2009. In the current study the children of the mothers participating in the main study are invited to the follow-up study "Trip Tooth Study" with data collection (dental examination) taking place over a time span of two years.

    2016 - 2017

Secondary Outcomes (2)

  • Enamel defects in the primary teeth of the children at the age of 7-9 yrs

    2016 - 2017

  • Antimicrobial peptides in saliva

    2016 - 2017

Interventions

The main focus of the dental examination is enamel defects and caries. Saliva samples (stimulated) will also be taken.

Eligibility Criteria

Age7 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

All n=855 mother/child pairs who participated in the initial TRIP study in 2007-2009 will be invited to participate in the follow-up study in 2016-2017.

You may qualify if:

  • Mother of the child participated in the main study "Training in Pregnancy"

You may not qualify if:

  • Consent not given

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva samples

MeSH Terms

Conditions

Vitamin D DeficiencyDental CariesDental Enamel Hypoplasia

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesTooth DemineralizationTooth DiseasesStomatognathic DiseasesDevelopmental Defects of EnamelTooth AbnormalitiesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Research

Study Record Dates

First Submitted

January 24, 2016

First Posted

September 6, 2017

Study Start

June 1, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

September 6, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be made available for sharing data.