Study of Vitamin D Supplementation on Improvement of Gums Health

NCT ID: NCT01422122

Last Updated: 2017-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2011-12-31

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.

Conditions

Gingival and Periodontal Disease; Deficiency of Vitamin D3; Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Vitamin D

Oral vitamin D3 in syrup form

Group Type: EXPERIMENTAL

Vitamin D3

Intervention Type: DRUG

4000 mg per day, one tablespoon syrup per day

placebo

Placebo syrup identical in colour and taste to that of intervention

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

one table spoon Syrup per day

Interventions

Vitamin D3

4000 mg per day, one tablespoon syrup per day

Intervention Type: DRUG

Placebo

one table spoon Syrup per day

Intervention Type: DRUG

Other Intervention Names

Vitamin D; Cholecaciferol; placebo syrup

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aga Khan University

OTHER

Sponsor Role: lead

Responsible Party

Farhan Raza Khan

Consultant, Dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zulfiqar A Bhutta, FRCPCH, PhD

Role: PRINCIPAL_INVESTIGATOR

Aga Khan University

Locations

AKU, Women & Child Health Outreach Office

Pind Dadan Khan, Punjab Province, Pakistan

Countries

Pakistan

References

Palacios C, Kostiuk LL, Cuthbert A, Weeks J. Vitamin D supplementation for women during pregnancy. Cochrane Database Syst Rev. 2024 Jul 30;7(7):CD008873. doi: 10.1002/14651858.CD008873.pub5.

Reference Type: DERIVED

PMID: 39077939 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31473727 (View on PubMed)

Other Identifiers

Aga Khan University

Identifier Type: OTHER

Identifier Source: secondary_id

1479-Ped-ERC-10

Identifier Type: -

Identifier Source: org_study_id