NCT01422122

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Aga Khan University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Vitamin D3	4000 mg per day, one tablespoon syrup per day
DRUG	Placebo	one table spoon Syrup per day

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-10-01
• Completion: 2011-12-01
• First posted: 2011-08-23
• Last updated: 2017-04-20

Locations

1 site across 1 country: Pakistan