Study of Vitamin D Supplementation on Improvement of Gums Health (VitaminD)
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
Gingival and Periodontal Disease
Deficiency of Vitamin D3
Drug: Vitamin D3
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Effect of Vitamin D Supplementation on the Periodontal Health and Associated Outcomes in Pregnant Women|
- Periodontal Probing Depth [ Time Frame: 6 months ] [ Designated as safety issue: No ]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)
- Interleukin 6 (IL-6) levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]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
|Study Start Date:||June 2010|
|Study Completion Date:||December 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Experimental: Vitamin D
oral vitamin D3
Drug: Vitamin D3
4000 mg per day, one tablespoon syrup per day
|Placebo Comparator: placebo||
one table spoon Syrup per day
Other Name: placebo syrup
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01422122
|AKU, Women & Child Health Outreach Office|
|Pind Dadan Khan, Punjab, Pakistan|
|Principal Investigator:||Zulfiqar A Bhutta, FRCPCH, PhD||Aga Khan University|