Vitamin D DeficiencyNCT03273725
Maternal Vitamin D Levels in Pregnancy and Dental Caries in Children
An observational study of Vitamin D Deficiency and Dental Caries, run by Tannhelsetjenestens Kompetansesenter Midt-Norge.
Trial 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 more about this study
- Who is it for?
- Ages 7 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Dental Caries, Dental Enamel Hypoplasia
- What is being tested?
- Dental examination including taking a saliva sample.
- How many people
- 178 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Mother of the child participated in the main study "Training in Pregnancy"
Who cannot join
- Consent not given
About this study
Official title: The TRIP-Tooth Study: Maternal Pre- and Postnatal Vitamin D Levels and Dental Caries in Children 7-9 Years of Age.
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.
- Being tested
- Dental examination including taking a saliva sample.
- Keywords
- Oral Health, Vitamin D
- Medical subject headings
- Vitamin D Deficiency, Dental Caries, Dental Enamel Hypoplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental examination including taking a saliva sample.Other
The main focus of the dental examination is enamel defects and caries. Saliva samples (stimulated) will also be taken.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2016 - 2017
Secondary outcomes (2)
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.
Measured: 2016 - 2017
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.
Measured: 2016 - 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study startJun 2016
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tannhelsetjenestens Kompetansesenter Midt-Norge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tone Natland Fagerhaug, Tannhelsetjenestens Kompetansesenter Midt-Norge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03273725
- Sponsor's protocol ID
- TannhelsetjenestensKM
- Status last verified
- Sep 2017
- First submitted
- 24 Jan 2016
- Last updated
- 6 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual participant data will not be made available for sharing data.
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The TRIP-Tooth Study: Maternal Pre- and Postnatal Vitamin D Levels and Dental Caries in Children 7-9 Years of Age.
- ClinicalTrials.gov ID
- NCT03273725
- Acronym / sponsor ID
- TannhelsetjenestensKM
- Keywords
- Oral Health, Vitamin D
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Tannhelsetjenestens Kompetansesenter Midt-NorgeUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 6 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Mother of the child participated in the main study "Training in Pregnancy"
Key exclusion criteria (1 listed)
- Consent not given
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental 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. | Other | – |
Primary outcome
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.
2 secondary outcomes
Enamel defects in the primary teeth of the children at the age of 7-9 yrs
Time frame: 2016 - 2017
Antimicrobial peptides in saliva
Time frame: 2016 - 2017
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2017.
- Individual participant dataSharing planned: No. Individual participant data will not be made available for sharing data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency and Dental Caries, run by Tannhelsetjenestens Kompetansesenter Midt-Norge.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental caries in the primary teeth of the children at the age of 7-9 yrs (time frame: 2016 - 2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2017.