Vitamin D DeficiencyNCT03158155
Prevalence of Early Childhood Caries in Egyptian Children With Serum Vitamin D Deficiency.
An observational study of Vitamin D Deficiency, run by Nancy Ahmed El Salmawy.
Trial summary
To detect the effect of vitamin D deficiency in the development of early childhood caries (ECC) among Egyptian children. Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- How many people
- 288 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2017to 18 Jul 2018
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Egyptain children age ranges from 2 to 5 years from Abo El Rish Hospital, Malnutrition clinic.
Who may be able to join
- Children ages from two to five years
- Both sexes.
- Parent and children cooperation.
- Healthy children.
- Children with serum vitamin D deficiency.
Who cannot join
- Children age more than 5 years.
- Children had a complex metabolic or medical disorder.
- Parents that will not sign the consent.
Trial locations and contacts
No sites are listed yet.
About this study
To detect the effect of vitamin D deficiency in the development of early childhood caries (ECC) among Egyptian children.
Read the detailed description
Justification for undertaking the trial:
American Academy of Pediatric Dentistry (2012), defined early childhood caries (ECC) as the presence of one or more decayed, missing teeth (resulting from caries), or filled surfaces in the primary tooth of child 6 years old or younger.
Early childhood caries is a chronic childhood disease, that decreasing quality of life, this include pain, disturbed sleep, poor aesthetics, difficulty in eating and speaking and behavioral changes that affect the child's self-esteem. (Guay, 2004).
Due to the rising incidence of dental carries in early childhood, contributory factors need to be investigated in order to facilitate treatment of such a large population of children in desperate need of dental care (Guay, 2004).These multiple risk factors include the lack of a dental home, poor oral hygiene, diet, and nutrition ( Najeeb et al., 2016).
Enamel is the most mineralized substance in the human body; it is mainly made of calcium and phosphate. Vitamin D plays an important role in increasing the absorption of calcium and phosphate from food. Which calcium and phosphate improve the strength of the teeth as make them able to fight the demineralization from bacteria (Youssef et al., 2011). Therefore, it is responsible of promoting the calcification of teeth, having a topical fluoride like effect, and in the forming of enamel, dentin, and bone. (Mellanby \& Pattison, 1928).
Vitamin D receptors are present on the cells of immune system and on the teeth. It binds to these receptors and increases the amount of good antimicrobial proteins as cathelicidin and other special defense in saliva (Youssef et al., 2011). These antimicrobial peptides have antibacterial neutralizing activity against periodonto pathogens as gram negative and gram positive bacteria and candida albicans, its effective in vitro against oral microorganisms such as streptococcus mutants, prophyromonas gingivalis and actinobacillus, so it prevents dental caries.( Potturu et al., 2014).
East, (1939) study concluded that children who consumed a high vitamin D diet, vitamin D played an indispensable role in 1) preventing the initiation of new caries, 2) inhibiting the spread of existing caries, and 3) arresting the caries. Likewise, an examination of children found a decreased caries prevalence in areas of increased vitamin D exposure.
- Conditions
- Vitamin D Deficiency
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with vitamin D deficiency | 1. children with vitamin D deficiency with age group from 2-5 years old |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of early childhood caries
Stages of Early childhood caries.
- Initial (reversible stage)
- Damaged (carious) stage
- Deep lesions
- Traumatic stage.
- Arrested caries.
Measured: 6 months
Secondary outcomes (2)
Delayed tooth formation and eruption
- Delayed tooth eruption.
- Tooth smaller than normal
Measured: 6 months
Gingivitis
binary yes or no
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start15 Jul 2017 (estimated)
- Primary completion15 Jul 2018 (estimated)
- Study completion18 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 288 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Nancy Ahmed El Salmawy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nancy Ahmed El Salmawy, Cairo University
- Investigators
- Nourhan A. El dokky, A. Professor, Study director, neldokky@hotmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03158155
- Sponsor's protocol ID
- CEBD-2017-5-101
- Status last verified
- Jun 2017
- First submitted
- 16 May 2017
- Last updated
- 7 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
American Academy on Pediatric Dentistry; American Academy of Pediatrics. Policy on early childhood caries (ECC): classifications, consequences, and preventive strategies. Pediatr Dent. 2008-2009;30(7 Suppl):40-3. No abstract available.
PubMed 19216381Anthonappa, R. P., and King, N. M. (2015). Enamel defects in the permanent dentition: prevalence and etiology. Springer-Verlag Berlin Heidelberg 2015; B.K. Drummond, N. Kilpatrick (eds.), Planning and Care for Children and Adolescents with Dental Enamel Defects: Etiology, Research and Contemporary Management, pp. 15-30
Antonenko O, Bryk G, Brito G, Pellegrini G, Zeni SN. Oral health in young women having a low calcium and vitamin D nutritional status. Clin Oral Investig. 2015 Jul;19(6):1199-206. doi: 10.1007/s00784-014-1343-x. Epub 2014 Oct 31.
PubMed 25359326Baumann, F., Jäger, E., & Bloch, W. (2013).Vitamin D -office of dietary supplements-National instituted health. Journal of Molecular Modeling
Bener, A., Al Darwish, M. S., and Hoffmann , G. F. (2013). Vitamin D deficiency and risk of dental caries among young children: A public health problem. Indian Journal of Oral Sciences, 4(2): 75-82
Bener A, Alsaied A, Al-Ali M, Al-Kubaisi A, Basha B, Abraham A, Guiter G, Mian M. High prevalence of vitamin D deficiency in type 1 diabetes mellitus and healthy children. Acta Diabetol. 2009 Sep;46(3):183-9. doi: 10.1007/s00592-008-0071-6. Epub 2008 Oct 10.
PubMed 18846317Wagner CL, Greer FR; American Academy of Pediatrics Section on Breastfeeding; American Academy of Pediatrics Committee on Nutrition. Prevention of rickets and vitamin D deficiency in infants, children, and adolescents. Pediatrics. 2008 Nov;122(5):1142-52. doi: 10.1542/peds.2008-1862.
PubMed 18977996Douglass JM, Douglass AB, Silk HJ. A practical guide to infant oral health. Am Fam Physician. 2004 Dec 1;70(11):2113-20.
PubMed 15606059Dudding T, Thomas SJ, Duncan K, Lawlor DA, Timpson NJ. Re-Examining the Association between Vitamin D and Childhood Caries. PLoS One. 2015 Dec 21;10(12):e0143769. doi: 10.1371/journal.pone.0143769. eCollection 2015.
PubMed 26692013East BR. Mean Annual Hours of Sunshine and the Incidence of Dental Caries. Am J Public Health Nations Health. 1939 Jul;29(7):777-80. doi: 10.2105/ajph.29.7.777. No abstract available.
PubMed 18015076Fuleihan Gel-H, Bouillon R, Clarke B, Chakhtoura M, Cooper C, McClung M, Singh RJ. Serum 25-Hydroxyvitamin D Levels: Variability, Knowledge Gaps, and the Concept of a Desirable Range. J Bone Miner Res. 2015 Jul;30(7):1119-33. doi: 10.1002/jbmr.2536. Epub 2015 May 7.
PubMed 25952470Grant WB. A review of the role of solar ultraviolet-B irradiance and vitamin D in reducing risk of dental caries. Dermatoendocrinol. 2011 Jul;3(3):193-8. doi: 10.4161/derm.3.3.15841. Epub 2011 Jul 1.
PubMed 22110779Guay AH. Access to dental care: solving the problem for underserved populations. J Am Dent Assoc. 2004 Nov;135(11):1599-605; quiz 1623. doi: 10.14219/jada.archive.2004.0088.
PubMed 15622666Herzog K, Scott JM, Hujoel P, Seminario AL. Association of vitamin D and dental caries in children: Findings from the National Health and Nutrition Examination Survey, 2005-2006. J Am Dent Assoc. 2016 Jun;147(6):413-20. doi: 10.1016/j.adaj.2015.12.013. Epub 2016 Jan 27.
PubMed 26827077Krall EA, Wehler C, Garcia RI, Harris SS, Dawson-Hughes B. Calcium and vitamin D supplements reduce tooth loss in the elderly. Am J Med. 2001 Oct 15;111(6):452-6. doi: 10.1016/s0002-9343(01)00899-3.
PubMed 11690570
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Early Childhood Caries in Egyptian Children With Serum Vitamin D Deficiency.
- ClinicalTrials.gov ID
- NCT03158155
- Acronym / sponsor ID
- CEBD-2017-5-101
- Conditions
- Vitamin D Deficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Nancy Ahmed El SalmawyUniversity, hospital or other
- Study start
- 15 Jul 2017 (estimated)
- Primary completion
- 15 Jul 2018 (estimated)
- Study completion
- 18 Jul 2018 (estimated)
- First posted
- 18 May 2017 (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.
To detect the effect of vitamin D deficiency in the development of early childhood caries (ECC) among Egyptian children.
Detailed description
Justification for undertaking the trial:
American Academy of Pediatric Dentistry (2012), defined early childhood caries (ECC) as the presence of one or more decayed, missing teeth (resulting from caries), or filled surfaces in the primary tooth of child 6 years old or younger.
Early childhood caries is a chronic childhood disease, that decreasing quality of life, this include pain, disturbed sleep, poor aesthetics, difficulty in eating and speaking and behavioral changes that affect the child's self-esteem. (Guay, 2004).
Due to the rising incidence of dental carries in early childhood, contributory factors need to be investigated in order to facilitate treatment of such a large population of children in desperate need of dental care (Guay, 2004).These multiple risk factors include the lack of a dental home, poor oral hygiene, diet, and nutrition ( Najeeb et al., 2016).
Enamel is the most mineralized substance in the human body; it is mainly made of calcium and phosphate. Vitamin D plays an important role in increasing the absorption of calcium and phosphate from food. Which calcium and phosphate improve the strength of the teeth as make them able to fight the demineralization from bacteria (Youssef et al., 2011). Therefore, it is responsible of promoting the calcification of teeth, having a topical fluoride like effect, and in the forming of enamel, dentin, and bone. (Mellanby \& Pattison, 1928).
Vitamin D receptors are present on the cells of immune system and on the teeth. It binds to these receptors and increases the amount of good antimicrobial proteins as cathelicidin and other special defense in saliva (Youssef et al., 2011). These antimicrobial peptides have antibacterial neutralizing activity against periodonto pathogens as gram negative and gram positive bacteria and candida albicans, its effective in vitro against oral microorganisms such as streptococcus mutants, prophyromonas gingivalis and actinobacillus, so it prevents dental caries.( Potturu et al., 2014).
East, (1939) study concluded that children who consumed a high vitamin D diet, vitamin D played an indispensable role in 1) preventing the initiation of new caries, 2) inhibiting the spread of existing caries, and 3) arresting the caries. Likewise, an examination of children found a decreased caries prevalence in areas of increased vitamin D exposure.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with vitamin D deficiency | – | –1. children with vitamin D deficiency with age group from 2-5 years old |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Egyptain children age ranges from 2 to 5 years from Abo El Rish Hospital, Malnutrition clinic.
Key inclusion criteria (5 listed)
- Children ages from two to five years
- Both sexes.
- Parent and children cooperation.
- Healthy children.
- Children with serum vitamin D deficiency.
Key exclusion criteria (3 listed)
- Children age more than 5 years.
- Children had a complex metabolic or medical disorder.
- Parents that will not sign the consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of early childhood caries
Time frame: 6 months
Stages of Early childhood caries. 1. Initial (reversible stage) 2. Damaged (carious) stage 3. Deep lesions 4. Traumatic stage. 5. Arrested caries.
2 secondary outcomes
Delayed tooth formation and eruption
Time frame: 6 months
Gingivitis
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.
- Background: PubMed 19216381American Academy on Pediatric Dentistry; American Academy of Pediatrics. Policy on early childhood caries (ECC): classifications, consequences, and preventive strategies. Pediatr Dent. 2008-2009;30(7 Suppl):40-3. No abstract available.
- BackgroundAnthonappa, R. P., and King, N. M. (2015). Enamel defects in the permanent dentition: prevalence and etiology. Springer-Verlag Berlin Heidelberg 2015; B.K. Drummond, N. Kilpatrick (eds.), Planning and Care for Children and Adolescents with Dental Enamel Defects: Etiology, Research and Contemporary Management, pp. 15-30
- Background: PubMed 25359326Antonenko O, Bryk G, Brito G, Pellegrini G, Zeni SN. Oral health in young women having a low calcium and vitamin D nutritional status. Clin Oral Investig. 2015 Jul;19(6):1199-206. doi: 10.1007/s00784-014-1343-x. Epub 2014 Oct 31.
- BackgroundBaumann, F., Jäger, E., & Bloch, W. (2013).Vitamin D -office of dietary supplements-National instituted health. Journal of Molecular Modeling
- BackgroundBener, A., Al Darwish, M. S., and Hoffmann , G. F. (2013). Vitamin D deficiency and risk of dental caries among young children: A public health problem. Indian Journal of Oral Sciences, 4(2): 75-82
- Background: PubMed 18846317Bener A, Alsaied A, Al-Ali M, Al-Kubaisi A, Basha B, Abraham A, Guiter G, Mian M. High prevalence of vitamin D deficiency in type 1 diabetes mellitus and healthy children. Acta Diabetol. 2009 Sep;46(3):183-9. doi: 10.1007/s00592-008-0071-6. Epub 2008 Oct 10.
- Background: PubMed 18977996Wagner CL, Greer FR; American Academy of Pediatrics Section on Breastfeeding; American Academy of Pediatrics Committee on Nutrition. Prevention of rickets and vitamin D deficiency in infants, children, and adolescents. Pediatrics. 2008 Nov;122(5):1142-52. doi: 10.1542/peds.2008-1862.
- Background: PubMed 15606059Douglass JM, Douglass AB, Silk HJ. A practical guide to infant oral health. Am Fam Physician. 2004 Dec 1;70(11):2113-20.
- Background: PubMed 26692013Dudding T, Thomas SJ, Duncan K, Lawlor DA, Timpson NJ. Re-Examining the Association between Vitamin D and Childhood Caries. PLoS One. 2015 Dec 21;10(12):e0143769. doi: 10.1371/journal.pone.0143769. eCollection 2015.
- Background: PubMed 18015076East BR. Mean Annual Hours of Sunshine and the Incidence of Dental Caries. Am J Public Health Nations Health. 1939 Jul;29(7):777-80. doi: 10.2105/ajph.29.7.777. No abstract available.
- Background: PubMed 25952470Fuleihan Gel-H, Bouillon R, Clarke B, Chakhtoura M, Cooper C, McClung M, Singh RJ. Serum 25-Hydroxyvitamin D Levels: Variability, Knowledge Gaps, and the Concept of a Desirable Range. J Bone Miner Res. 2015 Jul;30(7):1119-33. doi: 10.1002/jbmr.2536. Epub 2015 May 7.
- Background: PubMed 22110779Grant WB. A review of the role of solar ultraviolet-B irradiance and vitamin D in reducing risk of dental caries. Dermatoendocrinol. 2011 Jul;3(3):193-8. doi: 10.4161/derm.3.3.15841. Epub 2011 Jul 1.
- Individual participant dataSharing planned: Undecided
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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.
Nourhan A. El dokky, A. Professor study director
neldokky@hotmail.com
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency, run by Nancy Ahmed El Salmawy.
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 3 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: status not confirmed, as of the sponsor's last update on 7 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nancy A El salmawy, Master (+201001891010, nancyyy_911@hotmain.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of early childhood caries (time frame: 6 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 NCT03158155, which also lists 21 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 7 Jun 2017.