Study of Vitamin D Supplementation on Improvement of Gums Health

Pregnancy Clinical Trial

— VitaminD  

Official title:

The Effect of Vitamin D Supplementation on the Periodontal Health and Associated Outcomes in Pregnant Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01422122
• Other study ID #: 1479-Ped-ERC-10
• Secondary ID: Aga Khan Univers
• Status: Completed
• Phase: N/A
• First received: August 21, 2011
• Last updated: April 19, 2017
• Start date: June 2010
• Est. completion date: December 2011

Study information

• Verified date: April 2017
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Deficiency of Vitamin D3
• Gingival and Periodontal Disease
• Gingival Diseases
• Periodontal Diseases
• Pregnancy

Intervention

Drug:
• Vitamin D3
4000 mg per day, one tablespoon syrup per day
• Placebo
one table spoon Syrup per day

Locations

Country	Name	City	State
Pakistan	AKU, Women & Child Health Outreach Office	Pind Dadan Khan	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	6 months
Secondary	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-? and IL-17 will be determined	6 months