Clinical trial NCT01422122: Study of Vitamin D Supplementation on Improvement of Gums Health
Official title: The Effect of Vitamin D Supplementation on the Periodontal Health and Associated Outcomes in Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival and Periodontal Disease
Deficiency of Vitamin D3
Pregnancy
Keywords: vitamin D
pregnancy
periodontal health
biomarkers
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2011-08-23
Enrollment: 115
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Periodontal Probing Depth
timeFrame: 6 months
Secondary outcomes:
measure: Interleukin 6 (IL-6) levels
timeFrame: 6 months
Other outcomes:
Locations:
city: Pind Dadan Khan
country: Pakistan
facility: AKU, Women & Child Health Outreach Office
state: Punjab
Study officials:
affiliation: Aga Khan University
name: Zulfiqar A Bhutta, FRCPCH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Khan FR, Iqbal NT, Ahmed K, Ahmad T, Hussain R, Bhutta ZA. Effect of Vitamin D Supplementation on the Salivary Cytokines of Pregnant Women: A Randomized Placebo-Controlled Trial. J Int Acad Periodontol. 2017 Oct 1;19(4):118-125.