Vitamin D Status With Early Childhood Caries
Condition: Early Childhood Caries, Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      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).
    

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.
    

Intervention name(s): serum vitamin D , calcium , parathyroid hormone and albumin level
Intervention type(s): Diagnostic Test
Intervention description(s): measuring serum level of Vit. D, PTH, Calcium, and Albumin levels
Intervention MeSH terms: Vitamin D; Calcium; Parathyroid Hormone; Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Early childhood caries, Vitamin D deficiency, Parathyroid hormone, Calcium