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Completed

NCT Number: NCT01422122

Study of Vitamin D Supplementation on Improvement of Gums Health

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

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

AKU, Women & Child Health Outreach Office

Pind Dadan Khan, Punjab Province, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D3

Drug

4000 mg per day, one tablespoon syrup per day

Other names: Vitamin D, Cholecaciferol

Placebo

Drug

one table spoon Syrup per day

Other names: placebo syrup

Primary outcomes

  1. Periodontal Probing Depth

    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)

Secondary outcomes

  1. Interleukin 6 (IL-6) levels

    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

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Registry information

Official study title

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

Acronym: VitaminD

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 23, 2011
Registry last updated
Apr 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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