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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01422122
Recruitment Status : Completed
First Posted : August 23, 2011
Last Update Posted : April 20, 2017
Information provided by (Responsible Party):
Farhan Raza Khan, 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

Condition or disease Intervention/treatment Phase
Gingival and Periodontal Disease Deficiency of Vitamin D3 Pregnancy Drug: Vitamin D3 Drug: Placebo Not Applicable

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  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Vitamin D Supplementation on the Periodontal Health and Associated Outcomes in Pregnant Women
Study Start Date : June 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

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 Name: placebo syrup

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01422122

AKU, Women & Child Health Outreach Office
Pind Dadan Khan, Punjab, Pakistan
Sponsors and Collaborators
Aga Khan University
Principal Investigator: Zulfiqar A Bhutta, FRCPCH, PhD Aga Khan University

Responsible Party: Farhan Raza Khan, Consultant, Dentistry, Aga Khan University Identifier: NCT01422122     History of Changes
Other Study ID Numbers: 1479-Ped-ERC-10
Aga Khan University ( Other Identifier: Aga Khan University, division of child and maternal health )
First Posted: August 23, 2011    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Farhan Raza Khan, Aga Khan University:
vitamin D
periodontal health

Additional relevant MeSH terms:
Vitamin D
Periodontal Diseases
Gingival Diseases
Mouth Diseases
Stomatognathic Diseases
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents