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Maternal Vitamin D Levels in Pregnancy and Dental Caries in Children

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ClinicalTrials.gov Identifier: NCT03273725
Recruitment Status : Completed
First Posted : September 6, 2017
Last Update Posted : September 6, 2017
Sponsor:
Information provided by (Responsible Party):
Tone Natland Fagerhaug, Tannhelsetjenestens Kompetansesenter Midt-Norge

Tracking Information
First Submitted Date January 24, 2016
First Posted Date September 6, 2017
Last Update Posted Date September 6, 2017
Actual Study Start Date June 2016
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 1, 2017)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 1, 2017)
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Maternal Vitamin D Levels in Pregnancy and Dental Caries in Children
Official Title The TRIP-Tooth Study: Maternal Pre- and Postnatal Vitamin D Levels and Dental Caries in Children 7-9 Years of Age.
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.
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 Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Saliva samples
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.
Condition
  • Vitamin D Deficiency
  • Dental Caries
  • Dental Enamel Hypoplasia
Intervention Other: 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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 1, 2017)
178
Original Actual Enrollment Same as current
Actual Study Completion Date August 2017
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Consent not given
Sex/Gender
Sexes Eligible for Study: All
Ages 7 Years to 9 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03273725
Other Study ID Numbers TannhelsetjenestensKM
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Individual participant data will not be made available for sharing data.
Responsible Party Tone Natland Fagerhaug, Tannhelsetjenestens Kompetansesenter Midt-Norge
Study Sponsor Tannhelsetjenestens Kompetansesenter Midt-Norge
Collaborators Not Provided
Investigators Not Provided
PRS Account Tannhelsetjenestens Kompetansesenter Midt-Norge
Verification Date September 2017