Study of Vitamin D Supplementation on Improvement of Gums Health (VitaminD)

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

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

Study Overview

• Status: Completed
• Conditions: Pregnancy; Deficiency of Vitamin D3; Gingival and Periodontal Disease
• Intervention / Treatment: Drug: Vitamin D3; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Pind Dadan Khan, Punjab, Pakistan
      • AKU, Women & Child Health Outreach Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Vitamin D; Oral vitamin D3 in syrup form	Drug: Vitamin D3; 4000 mg per day, one tablespoon syrup per day; Other Names: Vitamin D; Cholecaciferol
PLACEBO_COMPARATOR: placebo; Placebo syrup identical in colour and taste to that of intervention	Drug: Placebo; one table spoon Syrup per day; Other Names: placebo syrup

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Aga Khan University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (ACTUAL): October 1, 2011
• Study Completion (ACTUAL): December 1, 2011

Study Registration Dates

• First Submitted: August 21, 2011
• First Submitted That Met QC Criteria: August 22, 2011
• First Posted (ESTIMATE): August 23, 2011

Study Record Updates

• Last Update Posted (ACTUAL): April 20, 2017
• Last Update Submitted That Met QC Criteria: April 19, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: biomarkers; pregnancy; vitamin D; periodontal health
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: 1479-Ped-ERC-10; Aga Khan University (OTHER: Aga Khan University, division of child and maternal health)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO