Study of Vitamin D Supplementation on Improvement of Gums Health

Not Applicable

Completed

• Conditions: Gingival and Periodontal Disease; Deficiency of Vitamin D3; Pregnancy
• Interventions: Drug: Vitamin D3; Drug: Placebo

• Registration Number: NCT01422122
• Lead Sponsor: Aga Khan University

Brief 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.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2011-08-21
• Study First Submitted QC: 2011-08-22
• Study First Posted: 2011-08-23
• Primary Completion: 2011-10
• Study Completion: 2011-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-19
• Last Update Posted: 2017-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 115

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D	Vitamin D3	Oral vitamin D3 in syrup form
placebo	Placebo	Placebo syrup identical in colour and taste to that of intervention

Primary Outcome Measures

Name	Time	Method
Periodontal Probing Depth	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)

Secondary Outcome Measures

Name	Time	Method
Interleukin 6 (IL-6) levels	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

Trial Locations

Locations (1)

AKU, Women & Child Health Outreach Office; 🇵🇰 Pind Dadan Khan, Punjab, Pakistan