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CompletedNCT03273725Updated Sep 6, 2017

Maternal Vitamin D Levels in Pregnancy and Dental Caries in Children

An observational study in Vitamin D Deficiency, Dental Caries and Dental Enamel Hypoplasia, sponsored by Tannhelsetjenestens Kompetansesenter Midt-Norge. Completed. Open to participants aged 7 Years to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-06.

Sponsored by Tannhelsetjenestens Kompetansesenter Midt-Norge · Observational

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Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
178
Ages
7 Years to 9 Years
Sex
All
01

Study 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.

Read the detailed description

Vitamin D plays an important part in calcium absorption needed for calcification of hard tissues such as bone. Lack of vitamin D can lead to growth retardation in children and a variety of bone related problems in adulthood such as osteopenia, osteoporosis and increased risk of bone fracture. Vitamin D deficiency has also been associated with a variety of other health problems. In relation to oral health, studies have suggested that lack of vitamin D may interfere with tooth development resulting in development defects of the enamel, which in turn increase the risk of dental caries. As teeth begin to calcify around 14 weeks in utero and continue until the enamel on the last primary tooth is completed around ten months after birth, it is plausible that both pre- and postnatal vitamin D levels can have an impact on the development of the enamel in primary teeth in the offspring, which in turn may be related to the risk of developing enamel defects and dental caries. Furthermore, vitamin D may play a role in the immune system and thereby affect the oral microflora. Vitamin D could therefore also affect the risk of caries through immunological pathways. Few previous studies have investigated the associations between vitamin D and oral health outcomes, such as these.

The aim of this study is to investigate the potential associations between maternal pre- and postnatal vitamin D levels and oral health outcomes, such as caries and dental enamel defects in the offspring at 7-9 years of age.

The current study is a follow-up study of a previous study conducted in Trondheim and Stavanger, Norway. In 2007-2009 a total of 855 pregnant women participated in the Training in Pregnancy (TRIP) study, a randomised controlled trial study conducted to investigate whether exercise during pregnancy would help prevent or treat various pregnancy related illnesses. The women were included between weeks 18-22 of pregnancy and were followed-up at week 32-36 of pregnancy and at 3 months post-partum. An additional follow-up was also conducted among the participants from Trondheim at 18 months post-partum. The data collection included both questionnaires, clinical examinations and blood samples. The blood samples taken from the mothers at 18-22 weeks and 32-36 weeks of pregnancy have been analysed for levels of vitamin D, calcium, phosphate, magnesium, creatinine, albumin and PTH. In the current study, the children are invited to a dental examination, including a saliva sample. These clinical examinations will be conducted from June 2016 through to August 2017.

02

Conditions studied

  • Vitamin D Deficiency
  • Dental Caries
  • Dental Enamel Hypoplasia

Keywords

  • Oral Health
  • Vitamin D
03

In context

Vitamin D Deficiency

801 studies on the registry are indexed under Vitamin D Deficiency; 60 are open to participants now.

This study's enrollment of 178 is above the median of 138 across 185 observational studies indexed under Vitamin D Deficiency.

Browse Vitamin D Deficiency studies →

Lead sponsor

This is the only study on the registry with Tannhelsetjenestens Kompetansesenter Midt-Norge as lead sponsor.

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

04

Who can participate

Ages eligible
7 Years to 9 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-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.

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

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

Exclusion criteria

Exclusion Criteria:

  • Consent not given
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
178 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • OtherDental examination including taking a saliva sample.

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

06

What researchers measure

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.

    Time frame: 2016 - 2017

Secondary outcomes

  1. Enamel defects 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.

    Time frame: 2016 - 2017

  2. Antimicrobial peptides in saliva

    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 including a saliva sample) taking place over a time span of two years.

    Time frame: 2016 - 2017

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be made available for sharing data.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2016 to primary completion in Aug 2017, 14 months.

Of 61 non-industry observational studies under Vitamin D Deficiency, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 40. This study's 14 months is below that.

Counting every sponsor, half of 62 studies reached it within 19 months; a quarter within 9 and three quarters within 40.

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

Registered
Jan 24, 2016
First posted
Sep 6, 2017
StartActual
Jun 2016
Primary completionActual
Aug 2017
CompletionActual
Aug 2017
Last update
Sep 6, 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 Sep 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03273725
Lead sponsor
Tannhelsetjenestens Kompetansesenter Midt-Norge
Responsible party
Tone Natland Fagerhaug (Head of Research, Tannhelsetjenestens Kompetansesenter Midt-Norge) — Principal investigator
First posted
Sep 6, 2017
Start date
Jun 2016
Primary completion
Aug 2017
Completion
Aug 2017
Last update
Sep 6, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

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