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

Primary Purpose

Gingival and Periodontal Disease, Deficiency of Vitamin D3, Pregnancy

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Vitamin D3
Placebo
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival and Periodontal Disease focused on measuring vitamin D, pregnancy, periodontal health, biomarkers

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • AKU, Women & Child Health Outreach Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin D

placebo

Arm Description

Oral vitamin D3 in syrup form

Placebo syrup identical in colour and taste to that of intervention

Outcomes

Primary Outcome Measures

Periodontal Probing Depth
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)

Secondary Outcome Measures

Interleukin 6 (IL-6) levels
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

Full Information

First Posted
August 21, 2011
Last Updated
April 19, 2017
Sponsor
Aga Khan University
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1. Study Identification

Unique Protocol Identification Number
NCT01422122
Brief Title
Study of Vitamin D Supplementation on Improvement of Gums Health
Acronym
VitaminD
Official Title
The Effect of Vitamin D Supplementation on the Periodontal Health and Associated Outcomes in Pregnant Women
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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 Vitamin D supplementation during pregnancy improves the periodontal health. There is an association between inflammatory biomarkers and periodontal health of pregnant females. Vitamin D supplementation improves the outcomes of pregnancy such as prematurity rates and birth weight
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival and Periodontal Disease, Deficiency of Vitamin D3, Pregnancy
Keywords
vitamin D, pregnancy, periodontal health, biomarkers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D
Arm Type
Experimental
Arm Description
Oral vitamin D3 in syrup form
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo syrup identical in colour and taste to that of intervention
Intervention Type
Drug
Intervention Name(s)
Vitamin D3
Other Intervention Name(s)
Vitamin D, Cholecaciferol
Intervention Description
4000 mg per day, one tablespoon syrup per day
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
placebo syrup
Intervention Description
one table spoon Syrup per day
Primary Outcome Measure Information:
Title
Periodontal Probing Depth
Description
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)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Interleukin 6 (IL-6) levels
Description
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
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zulfiqar A Bhutta, FRCPCH, PhD
Organizational Affiliation
Aga Khan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
AKU, Women & Child Health Outreach Office
City
Pind Dadan Khan
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31473727
Citation
Khan FR, Iqbal NT, Ahmed K, Ahmad T, Hussain R, Bhutta ZA. Effect of Vitamin D Supplementation on the Salivary Cytokines of Pregnant Women: A Randomized Placebo-Controlled Trial. J Int Acad Periodontol. 2017 Oct 1;19(4):118-125.
Results Reference
derived

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Study of Vitamin D Supplementation on Improvement of Gums Health

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