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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Farhan Raza Khan, Aga Khan University
ClinicalTrials.gov Identifier:
NCT01422122
First received: August 21, 2011
Last updated: August 8, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Gingival and Periodontal Disease
Deficiency of Vitamin D3
Pregnancy
Drug: Vitamin D3
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Vitamin D Supplementation on the Periodontal Health and Associated Outcomes in Pregnant Women

Resource links provided by NLM:


Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • Periodontal Probing Depth [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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:
  • Interleukin 6 (IL-6) levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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


Enrollment: 115
Study Start Date: June 2010
Study Completion Date: December 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D
oral vitamin D3
Drug: Vitamin D3
4000 mg per day, one tablespoon syrup per day
Other Names:
  • Vitamin D
  • Cholecaciferol
Placebo Comparator: placebo Drug: Placebo
one table spoon Syrup per day
Other Name: placebo syrup

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01422122

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

No publications provided

Responsible Party: Farhan Raza Khan, Consultant, Dentistry, Aga Khan University
ClinicalTrials.gov Identifier: NCT01422122     History of Changes
Other Study ID Numbers: 1479-Ped-ERC-2010, Aga Khan University
Study First Received: August 21, 2011
Last Updated: August 8, 2012
Health Authority: Pakistan: Research Ethics Committee

Keywords provided by Aga Khan University:
vitamin D
pregnancy
periodontal health
biomarkers

Additional relevant MeSH terms:
Periodontal Diseases
Gingival Diseases
Mouth Diseases
Stomatognathic Diseases
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 01, 2014