Study of Vitamin D Supplementation on Improvement of Gums Health

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gingival and Periodontal Disease, Deficiency of Vitamin D3, Pregnancy

Intervention / Treatment
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* Drug: Vitamin D3
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D<br>Oral vitamin D3 in syrup form | Drug: Vitamin D3<br>* 4000 mg per day, one tablespoon syrup per day<br>* Other names: Cholecaciferol;|
| Placebo Comparator: placebo<br>Placebo syrup identical in colour and taste to that of intervention | Drug: Placebo<br>* one table spoon Syrup per day<br>* Other names: placebo syrup;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin D, pregnancy, periodontal health, biomarkers