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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Saudi Arabia1 site
  • Reem Al-Nathsha

    Riyadh

Other trials in Saudi Arabia

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 groups in NCT03521492
Study groupRoleWhat they receive
caries groupExperimentalNot described
Receives: Diagnostic Test: serum vitamin D , calcium , parathyroid hormone and albumin level
free caries groupExperimentalNot 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.

  1. 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.

  1. First posted11 May 2018
  2. Study start30 Oct 2017
  3. Primary completion20 Feb 2018
  4. Study completion21 Mar 2018

Resources

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)
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 24160554
  • 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.

    PubMed 22811377
  • 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.

    PubMed 24753535
  • 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.

    PubMed 26553883
  • 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.

    PubMed 29465564

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.

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