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Study of Vitamin D Supplementation on Improvement of Gums Health (VitaminD)

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ClinicalTrials.gov Identifier: NCT01422122
Recruitment Status : Completed
First Posted : August 23, 2011
Last Update Posted : April 20, 2017
Sponsor:
Information provided by (Responsible Party):
Farhan Raza Khan, Aga Khan University

August 21, 2011
August 23, 2011
April 20, 2017
June 2010
October 2011   (Final data collection date for primary outcome measure)
Periodontal Probing Depth [ Time Frame: 6 months ]
Periodontal Probing Depth (PPD)is the distance between the gingival margin and the base of the pocket in millimeters). Clinical Attachment Loss (CAL) will also be determined (in mm)
Same as current
Complete list of historical versions of study NCT01422122 on ClinicalTrials.gov Archive Site
Interleukin 6 (IL-6) levels [ Time Frame: 6 months ]
Interleukin 6 (IL-6), is a biomarker of inflammation using CBA kit on Multiplex ELISA. Other biomarkers such as IL-2, IL-4, IL-10, TNF, IFN-ɣ and IL-17 will be determined
Same as current
Not Provided
Not Provided
 
Study of Vitamin D Supplementation on Improvement of Gums Health
The Effect of Vitamin D Supplementation on the Periodontal Health and Associated Outcomes in Pregnant Women

There is a gap in knowledge regarding the effects of Vitamin D supplementation on periodontal status in pregnant wome. The investigators aim to evaluate the potential benefit, if any of vitamin D supplementation during pregnancy on periodontal disease and relevant outcomes including burden of infections and prematurity rates.

the investigators hypothesize that

  1. Vitamin D supplementation during pregnancy improves the periodontal health.
  2. There is an association between inflammatory biomarkers and periodontal health of pregnant females.
  3. Vitamin D supplementation improves the outcomes of pregnancy such as prematurity rates and birth weight
Periodontal disease is one of the most common chronic infectious diseases known to humans, with a reported prevalence varying between 10%-60% in adults. Periodontal health is commonly affected in pregnancy. The prevalence of pregnancy gingivitis varies widely, ranging from around 35%- 100%. Although, most of the periodontal changes during pregnancy are reversible but females with preexisting periodontitis or those who have metabolic disease such as diabetes may suffer increased periodontal destruction and may exhibit significantly greater probing pocket depth and attachment level. Periodontal disease, as a source of persistent infection, may induce systemic inflammatory responses that increase the risk of adverse pregnancy outcomes. However, so far the results have been mixed. As vitamin D metabolites may also alter the inflammatory response and have antimicrobial effects thus the use of vitamin D may affect periodontal status. Evidence is there which suggests that an association exists between low serum levels of Vitamin D and periodontal attachment loss. If the investigators take all of the above factors in consideration, the broad picture reveals that as vitamin D deficiency is prevalent in Pakistan, the pregnant females here are likely to have compromised periodontal health and probably poor pregnancy outcomes.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Gingival and Periodontal Disease
  • Deficiency of Vitamin D3
  • Pregnancy
  • Drug: Vitamin D3
    4000 mg per day, one tablespoon syrup per day
    Other Names:
    • Vitamin D
    • Cholecaciferol
  • Drug: Placebo
    one table spoon Syrup per day
    Other Name: placebo syrup
  • Experimental: Vitamin D
    Oral vitamin D3 in syrup form
    Intervention: Drug: Vitamin D3
  • Placebo Comparator: placebo
    Placebo syrup identical in colour and taste to that of intervention
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
115
Same as current
December 2011
October 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pregnant females from 12-20 weeks of gestation who agree to participate in the study.
  • Presence of at least 20 natural teeth in mouth excluding third molars.
  • For controls: Non pregnant, healthy females matched with pregnant with respect to age and education.

Exclusion Criteria:

  • Pregnant females with high Vitamin D levels,
  • Women with metabolic diseases such as diabetes (type 1 or 2).
  • Presence of acute dental or periodontal disease
  • Presence of systemic disease and/or medication affecting the periodontium;
  • Receipt of systemic antibiotic treatment or dental prophylaxis in the previous 3 months and those who do not provide informed consent
Sexes Eligible for Study: Female
18 Years to 45 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Pakistan
 
 
NCT01422122
1479-Ped-ERC-10
Aga Khan University ( Other Identifier: Aga Khan University, division of child and maternal health )
Yes
Not Provided
Plan to Share IPD: No
Farhan Raza Khan, Aga Khan University
Aga Khan University
Not Provided
Principal Investigator: Zulfiqar A Bhutta, FRCPCH, PhD Aga Khan University
Aga Khan University
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP