Vitamin D Status With Early Childhood Caries
Primary Purpose
Early Childhood Caries, Vitamin D Deficiency
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
serum vitamin D , calcium , parathyroid hormone and albumin level
Sponsored by
About this trial
This is an interventional prevention trial for Early Childhood Caries, Vitamin D Deficiency focused on measuring Early childhood caries, Vitamin D deficiency, Parathyroid hormone, Calcium
Eligibility Criteria
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.
Sites / Locations
- Reem Al-Nathsha
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
caries group
free caries group
Arm Description
Outcomes
Primary Outcome Measures
vitamin D level of caries and caries free groups
Secondary Outcome Measures
Full Information
NCT ID
NCT03521492
First Posted
April 27, 2018
Last Updated
May 10, 2018
Sponsor
Ministry of Health, Saudi Arabia
1. Study Identification
Unique Protocol Identification Number
NCT03521492
Brief Title
Vitamin D Status With Early Childhood Caries
Official Title
The Relationship Between Vitamin D Status and Early Childhood Caries Development: A Case-Control Piolet Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
October 30, 2017 (Actual)
Primary Completion Date
February 20, 2018 (Actual)
Study Completion Date
March 21, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Health, Saudi Arabia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Childhood Caries, Vitamin D Deficiency
Keywords
Early childhood caries, Vitamin D deficiency, Parathyroid hormone, Calcium
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
caries group
Arm Type
Experimental
Arm Title
free caries group
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
serum vitamin D , calcium , parathyroid hormone and albumin level
Intervention Description
measuring serum level of Vit. D, PTH, Calcium, and Albumin levels
Primary Outcome Measure Information:
Title
vitamin D level of caries and caries free groups
Time Frame
7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ghazi S. Alenazi, MSC
Organizational Affiliation
M.O.H.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reem Al-Nathsha
City
Riyadh
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24160554
Citation
Schroth RJ, Levi JA, Sellers EA, Friel J, Kliewer E, Moffatt ME. Vitamin D status of children with severe early childhood caries: a case-control study. BMC Pediatr. 2013 Oct 25;13:174. doi: 10.1186/1471-2431-13-174.
Results Reference
result
PubMed Identifier
22811377
Citation
Schroth RJ, Jeal NS, Kliewer E, Sellers EA. The relationship between vitamin D and severe early childhood caries: a pilot study. Int J Vitam Nutr Res. 2012 Feb;82(1):53-62. doi: 10.1024/0300-9831/a000094.
Results Reference
result
PubMed Identifier
24753535
Citation
Schroth RJ, Lavelle C, Tate R, Bruce S, Billings RJ, Moffatt ME. Prenatal vitamin D and dental caries in infants. Pediatrics. 2014 May;133(5):e1277-84. doi: 10.1542/peds.2013-2215.
Results Reference
result
PubMed Identifier
26553883
Citation
Schroth RJ, Rabbani R, Loewen G, Moffatt ME. Vitamin D and Dental Caries in Children. J Dent Res. 2016 Feb;95(2):173-9. doi: 10.1177/0022034515616335. Epub 2015 Nov 9.
Results Reference
result
PubMed Identifier
29465564
Citation
Wojcik D, Krzewska A, Szalewski L, Pietryka-Michalowska E, Szalewska M, Krzewski S, Pels E, Ben-Skowronek I. Dental caries and vitamin D3 in children with growth hormone deficiency: A STROBE compliant study. Medicine (Baltimore). 2018 Feb;97(8):e9811. doi: 10.1097/MD.0000000000009811.
Results Reference
result
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Vitamin D Status With Early Childhood Caries
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