NCT01422122

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. 1.Vitamin D supplementation during pregnancy improves the periodontal health.
  2. 2.There is an association between inflammatory biomarkers and periodontal health of pregnant females.
  3. 3.Vitamin D supplementation improves the outcomes of pregnancy such as prematurity rates and birth weight

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 23, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

April 20, 2017

Status Verified

April 1, 2017

Enrollment Period

1.3 years

First QC Date

August 21, 2011

Last Update Submit

April 19, 2017

Conditions

Gingival and Periodontal DiseaseDeficiency of Vitamin D3Pregnancy

Keywords

vitamin Dpregnancyperiodontal healthbiomarkers

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Interleukin 6 (IL-6) levels

    6 months

Study Arms (2)

Vitamin D

EXPERIMENTAL

Oral vitamin D3 in syrup form

Drug: Vitamin D3

placebo

PLACEBO COMPARATOR

Placebo syrup identical in colour and taste to that of intervention

Drug: Placebo

Interventions

Vitamin D3DRUG

4000 mg per day, one tablespoon syrup per day

Also known as: Vitamin D, Cholecaciferol
Vitamin D
PlaceboDRUG

one table spoon Syrup per day

Also known as: placebo syrup
placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AKU, Women & Child Health Outreach Office

Pind Dadan Khan, Punjab Province, Pakistan

Location

Related Publications (2)

  • 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.

    PMID: 39077939DERIVED

  • 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.

    PMID: 31473727DERIVED

MeSH Terms

Conditions

Periodontal Diseases

Interventions

CholecalciferolVitamin D

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsSecosteroidsMembrane LipidsLipids

Study Officials

  • Zulfiqar A Bhutta, FRCPCH, PhD

    Aga Khan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant, Dentistry

Study Record Dates

First Submitted

August 21, 2011

First Posted

August 23, 2011

Study Start

June 1, 2010

Primary Completion

October 1, 2011

Study Completion

December 1, 2011

Last Updated

April 20, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)