- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03273725
Maternal Vitamin D Levels in Pregnancy and Dental Caries in Children
The TRIP-Tooth Study: Maternal Pre- and Postnatal Vitamin D Levels and Dental Caries in Children 7-9 Years of Age.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Mother of the child participated in the main study "Training in Pregnancy"
Exclusion Criteria:
- Consent not given
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dental caries in the primary teeth of the children at the age of 7-9 yrs
Time Frame: 2016 - 2017
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Enamel defects in the primary teeth of the children at the age of 7-9 yrs
Time Frame: 2016 - 2017
|
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
|
|
Antimicrobial peptides in saliva
Time Frame: 2016 - 2017
|
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.
|
2016 - 2017
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TannhelsetjenestensKM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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