<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03273725</url>
  </required_header>
  <id_info>
    <org_study_id>TannhelsetjenestensKM</org_study_id>
    <nct_id>NCT03273725</nct_id>
  </id_info>
  <brief_title>Maternal Vitamin D Levels in Pregnancy and Dental Caries in Children</brief_title>
  <official_title>The TRIP-Tooth Study: Maternal Pre- and Postnatal Vitamin D Levels and Dental Caries in Children 7-9 Years of Age.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tannhelsetjenestens Kompetansesenter Midt-Norge</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tannhelsetjenestens Kompetansesenter Midt-Norge</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main aim of this study is to investigate potential associations between maternal pre- and&#xD;
      postnatal vitamin D level and oral health outcomes (caries and developmental defects of&#xD;
      enamel) in their children at 7-9 years of age.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Vitamin D plays an important part in calcium absorption needed for calcification of hard&#xD;
      tissues such as bone. Lack of vitamin D can lead to growth retardation in children and a&#xD;
      variety of bone related problems in adulthood such as osteopenia, osteoporosis and increased&#xD;
      risk of bone fracture. Vitamin D deficiency has also been associated with a variety of other&#xD;
      health problems. In relation to oral health, studies have suggested that lack of vitamin D&#xD;
      may interfere with tooth development resulting in development defects of the enamel, which in&#xD;
      turn increase the risk of dental caries. As teeth begin to calcify around 14 weeks in utero&#xD;
      and continue until the enamel on the last primary tooth is completed around ten months after&#xD;
      birth, it is plausible that both pre- and postnatal vitamin D levels can have an impact on&#xD;
      the development of the enamel in primary teeth in the offspring, which in turn may be related&#xD;
      to the risk of developing enamel defects and dental caries. Furthermore, vitamin D may play a&#xD;
      role in the immune system and thereby affect the oral microflora. Vitamin D could therefore&#xD;
      also affect the risk of caries through immunological pathways. Few previous studies have&#xD;
      investigated the associations between vitamin D and oral health outcomes, such as these.&#xD;
&#xD;
      The aim of this study is to investigate the potential associations between maternal pre- and&#xD;
      postnatal vitamin D levels and oral health outcomes, such as caries and dental enamel defects&#xD;
      in the offspring at 7-9 years of age.&#xD;
&#xD;
      The current study is a follow-up study of a previous study conducted in Trondheim and&#xD;
      Stavanger, Norway. In 2007-2009 a total of 855 pregnant women participated in the Training in&#xD;
      Pregnancy (TRIP) study, a randomised controlled trial study conducted to investigate whether&#xD;
      exercise during pregnancy would help prevent or treat various pregnancy related illnesses.&#xD;
      The women were included between weeks 18-22 of pregnancy and were followed-up at week 32-36&#xD;
      of pregnancy and at 3 months post-partum. An additional follow-up was also conducted among&#xD;
      the participants from Trondheim at 18 months post-partum. The data collection included both&#xD;
      questionnaires, clinical examinations and blood samples. The blood samples taken from the&#xD;
      mothers at 18-22 weeks and 32-36 weeks of pregnancy have been analysed for levels of vitamin&#xD;
      D, calcium, phosphate, magnesium, creatinine, albumin and PTH. In the current study, the&#xD;
      children are invited to a dental examination, including a saliva sample. These clinical&#xD;
      examinations will be conducted from June 2016 through to August 2017.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2016</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">August 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Dental caries in the primary teeth of the children at the age of 7-9 yrs</measure>
    <time_frame>2016 - 2017</time_frame>
    <description>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 &quot;Trip Tooth Study&quot; with data collection (dental examination) taking place over a time span of two years.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Enamel defects in the primary teeth of the children at the age of 7-9 yrs</measure>
    <time_frame>2016 - 2017</time_frame>
    <description>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 &quot;Trip Tooth Study&quot; with data collection (dental examination) taking place over a time span of two years.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antimicrobial peptides in saliva</measure>
    <time_frame>2016 - 2017</time_frame>
    <description>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 &quot;Trip Tooth Study&quot; with data collection (dental examination including a saliva sample) taking place over a time span of two years.</description>
  </secondary_outcome>
  <enrollment type="Actual">178</enrollment>
  <condition>Vitamin D Deficiency</condition>
  <condition>Dental Caries</condition>
  <condition>Dental Enamel Hypoplasia</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dental examination including taking a saliva sample.</intervention_name>
    <description>The main focus of the dental examination is enamel defects and caries. Saliva samples (stimulated) will also be taken.</description>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Saliva samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All n=855 mother/child pairs who participated in the initial TRIP study in 2007-2009 will&#xD;
        be invited to participate in the follow-up study in 2016-2017.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mother of the child participated in the main study &quot;Training in Pregnancy&quot;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Consent not given&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>9 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>January 24, 2016</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>September 1, 2017</last_update_submitted>
  <last_update_submitted_qc>September 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tannhelsetjenestens Kompetansesenter Midt-Norge</investigator_affiliation>
    <investigator_full_name>Tone Natland Fagerhaug</investigator_full_name>
    <investigator_title>Head of Research</investigator_title>
  </responsible_party>
  <keyword>Oral Health</keyword>
  <keyword>Vitamin D</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
    <mesh_term>Dental Enamel Hypoplasia</mesh_term>
    <mesh_term>Vitamin D Deficiency</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual participant data will not be made available for sharing data.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03273725
org study id: TannhelsetjenestensKM
nct id: NCT03273725
lead sponsor: 
has dmc: No
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.
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.
observational model: Other
time perspective: Prospective
measure: Dental caries in the primary teeth of the children at the age of 7-9 yrs
time frame: 2016 - 2017
description: 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.
measure: Enamel defects in the primary teeth of the children at the age of 7-9 yrs
time frame: 2016 - 2017
description: 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.
measure: Antimicrobial peptides in saliva
time frame: 2016 - 2017
description: 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.
intervention type: Other
intervention name: Dental examination including taking a saliva sample.
description: The main focus of the dental examination is enamel defects and caries. Saliva samples (stimulated) will also be taken.
Saliva samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 7 Years
maximum age: 9 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Tannhelsetjenestens Kompetansesenter Midt-Norge
investigator full name: Tone Natland Fagerhaug
investigator title: Head of Research
mesh term: Dental Caries
mesh term: Dental Enamel Hypoplasia
mesh term: Vitamin D Deficiency
sharing ipd: No
ipd description: Individual participant data will not be made available for sharing data.