NCT03158155

Brief Summary

To detect the effect of vitamin D deficiency in the development of early childhood caries (ECC) among Egyptian children.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
288

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 18, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

July 15, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2018

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2018

Completed
Last Updated

June 7, 2017

Status Verified

June 1, 2017

Enrollment Period

1 year

First QC Date

May 16, 2017

Last Update Submit

June 5, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of early childhood caries

    Stages of Early childhood caries. 1. Initial (reversible stage) 2. Damaged (carious) stage 3. Deep lesions 4. Traumatic stage. 5. Arrested caries.

    6 months

Secondary Outcomes (2)

  • Delayed tooth formation and eruption

    6 months

  • Gingivitis

    6 months

Study Arms (1)

Patients with vitamin D deficiency

1\. children with vitamin D deficiency with age group from 2-5 years old

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Egyptain children age ranges from 2 to 5 years from Abo El Rish Hospital, Malnutrition clinic.

You may qualify if:

  • Children ages from two to five years
  • Both sexes.
  • Parent and children cooperation.
  • Healthy children.
  • Children with serum vitamin D deficiency.

You may not qualify if:

  • Children age more than 5 years.
  • Children had a complex metabolic or medical disorder.
  • Parents that will not sign the consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (21)

  • Policy on Early Childhood Caries (ECC): Classifications, Consequences, and Preventive Strategies. Pediatr Dent. 2016 Oct;38(6):52-54. No abstract available.

    PMID: 27931420BACKGROUND
  • Anthonappa, 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
  • 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.

    PMID: 25359326BACKGROUND
  • Baumann, F., Jäger, E., & Bloch, W. (2013).Vitamin D -office of dietary supplements-National instituted health. Journal of Molecular Modeling

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 18846317BACKGROUND
  • Wagner 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.

    PMID: 18977996BACKGROUND
  • Douglass JM, Douglass AB, Silk HJ. A practical guide to infant oral health. Am Fam Physician. 2004 Dec 1;70(11):2113-20.

    PMID: 15606059BACKGROUND
  • Dudding 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.

    PMID: 26692013BACKGROUND
  • East 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.

    PMID: 18015076BACKGROUND
  • Fuleihan 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.

    PMID: 25952470BACKGROUND
  • Grant 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.

    PMID: 22110779BACKGROUND
  • Guay 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.

    PMID: 15622666BACKGROUND
  • Herzog 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.

    PMID: 26827077BACKGROUND
  • Krall 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.

    PMID: 11690570BACKGROUND
  • Mellanby M, Pattison CL. THE ACTION OF VITAMIN D IN PREVENTING THE SPREAD AND PROMOTING THE ARREST OF CARIES IN CHILDREN. Br Med J. 1928 Dec 15;2(3545):1079-82. doi: 10.1136/bmj.2.3545.1079. No abstract available.

    PMID: 20774325BACKGROUND
  • Najeeb S, Zafar MS, Khurshid Z, Zohaib S, Almas K. The Role of Nutrition in Periodontal Health: An Update. Nutrients. 2016 Aug 30;8(9):530. doi: 10.3390/nu8090530.

    PMID: 27589794BACKGROUND
  • Youssef DA, Miller CW, El-Abbassi AM, Cutchins DC, Cutchins C, Grant WB, Peiris AN. Antimicrobial implications of vitamin D. Dermatoendocrinol. 2011 Oct;3(4):220-9. doi: 10.4161/derm.3.4.15027. Epub 2011 Oct 1.

    PMID: 22259647BACKGROUND
  • Potturu, M., Prabhakaran, P. A., Oommen, N., Sarojini, D. M., and Sunil, S. N.(2014). Cathelicidin expression and role in oral health and diseases: A short review. Tropical J. of Med. Res., 17 (2): 69-75.

    BACKGROUND
  • 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.

    PMID: 24753535BACKGROUND
  • American Academy of Pediatric Dentistry Clinical Affairs Committee; American Academy of Pediatric Dentistry Council on Clinical Affairs. Guideline on periodicity of examination, preventive dental services, anticipatory guidance, and oral treatment for children. Pediatr Dent. 2005-2006;27(7 Suppl):84-6. No abstract available.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be obtained from children recruited in the study at the day of diagnosis, seven mm of blood will collect approximately, using radioimmunoassay technique for measuring vitamin D serum level All serum analysis will be done in Radioisotope Department, Nuclear Research Center, and Atomic Energy Authority.

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Nourhan A. El dokky, A. Professor

    neldokky@hotmail.com

    STUDY DIRECTOR

Central Study Contacts

Nancy A El salmawy, Master

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator,

Study Record Dates

First Submitted

May 16, 2017

First Posted

May 18, 2017

Study Start

July 15, 2017

Primary Completion

July 15, 2018

Study Completion

July 18, 2018

Last Updated

June 7, 2017

Record last verified: 2017-06