Early Childhood Caries, Vitamin D DeficiencyNCT03521492
Vitamin D Status With Early Childhood Caries
A study testing serum vitamin D , calcium , parathyroid hormone and albumin level in people with Early Childhood Caries, Vitamin D Deficiency, run by Ministry of Health, Saudi Arabia at 1 site in Saudi Arabia.
Trial 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). Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Early Childhood Caries, Vitamin D Deficiency
- What is being tested?
- serum vitamin D , calcium , parathyroid hormone and albumin level
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 30 Oct 2017to 21 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Being tested
- serum vitamin D , calcium , parathyroid hormone and albumin level
- Keywords
- Early childhood caries, Vitamin D deficiency, Parathyroid hormone, Calcium
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum vitamin D , calcium , parathyroid hormone and albumin levelDiagnostic test
measuring serum level of Vit. D, PTH, Calcium, and Albumin levels
| Study group | Role | What they receive |
|---|---|---|
| caries group | Experimental | Not described Receives: Diagnostic Test: serum vitamin D , calcium , parathyroid hormone and albumin level |
| free caries group | Experimental | Not described Receives: Diagnostic Test: serum vitamin D , calcium , parathyroid hormone and albumin level |
What is being measured
The primary outcome is the main question the study is designed to answer.
vitamin D level of caries and caries free groups
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start30 Oct 2017
- Primary completion20 Feb 2018
- Study completion21 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Early Childhood Caries, Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Saudi Arabia
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ghazi S. AlAnazi, Ministry of Health, Saudi Arabia
- Investigators
- Ghazi S. Alenazi, MSC, Principal investigator, M.O.H.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03521492
- Sponsor's protocol ID
- Serum Vitamin D Level
- Status last verified
- May 2018
- First submitted
- 27 Apr 2018
- Last updated
- 16 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24160554Schroth 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.
PubMed 22811377Schroth 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.
PubMed 24753535Schroth 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.
PubMed 26553883Wojcik 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.
PubMed 29465564
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Vitamin D Status and Early Childhood Caries Development: A Case-Control Piolet Study
- ClinicalTrials.gov ID
- NCT03521492
- Acronym / sponsor ID
- Serum Vitamin D Level
- Keywords
- Early childhood caries, Vitamin D deficiency, Parathyroid hormone, Calcium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ministry of Health, Saudi ArabiaOther government
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 20 Feb 2018 (actual)
- Study completion
- 21 Mar 2018 (actual)
- First posted
- 11 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| caries group | Experimental | Diagnostic Test: serum vitamin D , calcium , parathyroid hormone and albumin level |
| free caries group | Experimental | Diagnostic Test: serum vitamin D , calcium , parathyroid hormone and albumin level |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serum vitamin D , calcium , parathyroid hormone and albumin levelmeasuring serum level of Vit. D, PTH, Calcium, and Albumin levels | Diagnostic test | caries group, free caries group |
Primary outcome
vitamin D level of caries and caries free groups
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2018.
- Results publication: PubMed 24160554Schroth 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 publication: PubMed 22811377Schroth 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 publication: PubMed 24753535Schroth 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 publication: PubMed 26553883Schroth 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 publication: PubMed 29465564Wojcik 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ghazi S. Alenazi, MSC principal investigator
M.O.H.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing serum vitamin D , calcium , parathyroid hormone and albumin level in people with Early Childhood Caries, Vitamin D Deficiency, run by Ministry of Health, Saudi Arabia at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vitamin D level of caries and caries free groups (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03521492, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2018.