AKU, Women & Child Health Outreach Office
Pind Dadan Khan, Punjab Province, Pakistan
NCT Number: NCT01422122
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
Looking for future studies?
Notify Me18 year–45 year
Female
Interventional
Not applicable
Pind Dadan Khan, Punjab Province, Pakistan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
4000 mg per day, one tablespoon syrup per day
Other names: Vitamin D, Cholecaciferol
one table spoon Syrup per day
Other names: placebo syrup
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)
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
Aga Khan University
Other
The Effect of Vitamin D Supplementation on the Periodontal Health and Associated Outcomes in Pregnant Women
Acronym: VitaminD
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