Vitamin D Status With Early Childhood Caries

May 10, 2018 updated by: Ghazi S. AlAnazi, Ministry of Health, Saudi Arabia

The Relationship Between Vitamin D Status and Early Childhood Caries Development: A Case-Control Piolet Study

Studies that give people vitamin D supplements to prevent caries have found that vitamin D is effective at preventing the development of caries.

The aim of Study:

To determine if there is a relationship between vitamin D deficiency and the development of Early Childhood Caries (ECC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Methodology:

This is a case-control pilot study to determine the relationship of vitamin D deficiency to the prevalence and severity of ECC. Patient selection and examination following inclusion and exclusion criteria, an Informed consent form will obtain from the parent or guardian after explaining the study in detail. Patients have a yearly pediatric medicine exam and blood drawn regardless of their participation in the study.

Inclusion Criteria:

  • Cases: Patients diagnosed with ECC who are treatment planned to receive full mouth dental rehabilitation under General Anesthesia (GA).
  • Age 71 months or younger.
  • Patients with an American Society of Anesthesiologists (ASA) Classification of 1 (Healthy person).
  • Controls: patients who present with no frank cavitated lesions upon visual and radiographic examination who are:
  • Patients of record at SFH for an annual exam with blood work patients will schedule to undergo an otolaryngology procedure under GA.

Exclusion Criteria:

  • Patients with significant metabolic disorders and/or complex medical issues.
  • Patients with an ASA Classification of 2 or greater.
  • Patients received vitamin D supply
  • Controls: patients who present with frank cavitated lesions upon visual and radiographic examination.

Blood Samples:

The operating room (OR) staff obtained blood samples while the patient will be under GA prior to the initiation of dental treatment. An intravenous (IV) line will place while the child is in the OR for clinical purposes. No additional needle sticks will incur, as blood will draw from a clinically necessary IV line. The sample will obtain as a maximum fill of a Red topped 4.0 mL BD Vacutainer tube. Patients will assign a Research Medical Record Number in the Center Hospital database so that blood samples are correctly will analyze and tabulate when they will leave the OR. Phlebotomist obtained blood from the caries free controls, a topical anesthetic (EMLA) was applied to the antecubital fossa one hour prior to minimize discomfort from the venipuncture during their annual exams also assigned a research related identification number in the same manner.

Vitamin D Analyses:

All blood samples were analyzed for 25-OH Vitamin D levels, PTH level, Ca level and Albumin in Medical Laboratory. Total 25-OH Vitamin D was calculated as the sum total of 25-OH Vitamin D3 and 25-OH Vitamin D2. Lab results were entered into a database and chart for data analysis. PTH, Albumin and Ca levels were analyzed with the same blood sample in addition to 25(OH) D levels. PTH is a more sensitive surrogate for mild Vitamin D deficiency and is typically was analyzed in conjunction with Vitamin D. Analysis and report data are based on the following values: Deficient (< 35 nmol/L), Adequate (≥ 50 nmol/L), Optimal (≥ 75 nmol/L). Normal reference ranges were adopted for calcium (2.1-2.6 mmol/L), albumin (35-47 g/L for those < 48 months and 33-39 g/L for those ≥ 48 months), and PTH (7-50 ng/L). Blood work drawn was analyzed and any discrepancy in findings, such as vitamin D deficiency, was reported to the patient so that they will referrer for treatment by their pediatrician.

Statistical Analysis:

Analysis included descriptive statistics (frequencies, means ± Standard Deviations (SD)), Chi-square analysis, and t-tests. Unadjusted odds ratios (OR) and 95% confidence intervals (CI) were also calculated. Multiple regression analysis was performed for mean 25(OH)D including independent variables significantly associated with vitamin D levels on bivariate analysis or known to influence vitamin D status. Logistic regression for S-ECC including variables associated at the bivariate level was also performed. In both models, some variables were excluded when there was evidence of multi-colinearity. A p value ≤ 0.05 was significant. All analyses will be done by using SPSS 20 software at p ≤ 0.05.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Cases: Patients diagnosed with ECC who are treatment planned to receive full mouth dental rehabilitation under General Anesthesia (GA).
  • Age 71 months or younger.
  • Patients with an American Society of Anesthesiologists (ASA) Classification of 1 (Healthy person).
  • Controls: patients who present with no frank cavitated lesions upon visual and radiographic examination who are:
  • Patients of record at SFH for an annual exam with blood work patients will schedule to undergo an otolaryngology procedure under GA.

Exclusion Criteria:

Exclusion Criteria:

  • Patients with significant metabolic disorders and/or complex medical issues.
  • Patients with an ASA Classification of 2 or greater.
  • Patients received vitamin D supply
  • Controls: patients who present with frank cavitated lesions upon visual and radiographic examination.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: caries group
Diagnostic test: serum vitamin D , calcium , parathyroid hormone and albumin level
measuring serum level of Vit. D, PTH, Calcium, and Albumin levels
Experimental: free caries group
Diagnostic test: serum vitamin D , calcium , parathyroid hormone and albumin level
measuring serum level of Vit. D, PTH, Calcium, and Albumin levels

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
vitamin D level of caries and caries free groups
Time Frame: 7 months
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ministry of Health, Saudi Arabia

Investigators

  • Principal Investigator: Ghazi S. Alenazi, MSC, M.O.H.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2017

Primary Completion (Actual)

February 20, 2018

Study Completion (Actual)

March 21, 2018

Study Registration Dates

First Submitted

April 27, 2018

First Submitted That Met QC Criteria

April 27, 2018

First Posted (Actual)

May 11, 2018

Study Record Updates

Last Update Posted (Actual)

May 16, 2018

Last Update Submitted That Met QC Criteria

May 10, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Serum Vitamin D Level

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Study Data/Documents

  1. Individual Participant Data Set

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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