Gingival and Periodontal DiseaseVitaminDNCT01422122
Study of Vitamin D Supplementation on Improvement of Gums Health
A study testing Vitamin D3 in people with Gingival and Periodontal Disease and Deficiency of Vitamin D3, run by Aga Khan University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gingival and Periodontal Disease, Deficiency of Vitamin D3, Pregnancy
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 1 sitePakistan
- Study dates
- Jun 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
AKU, Women & Child Health Outreach Office
Pind Dadan Khan, Punjab Province
About this study
Official title: 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
- Vitamin D supplementation during pregnancy improves the periodontal health.
- There is an association between inflammatory biomarkers and periodontal health of pregnant females.
- Vitamin D supplementation improves the outcomes of pregnancy such as prematurity rates and birth weight
Read the 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.
- Being tested
- Vitamin D3, Placebo
- Keywords
- vitamin D, pregnancy, periodontal health, biomarkers
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
Also called Vitamin D, Cholecaciferol
4000 mg per day, one tablespoon syrup per day
PlaceboDrug
Also called placebo syrup
one table spoon Syrup per day
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Experimental | Oral vitamin D3 in syrup form Receives: Drug: Vitamin D3 |
| placebo | Placebo comparator | Placebo syrup identical in colour and taste to that of intervention Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Secondary outcomes (1)
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2011 (estimated)
- Study startJun 2010
- Primary completionOct 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gingival and Periodontal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farhan Raza Khan, Aga Khan University
- Investigators
- Zulfiqar A Bhutta, FRCPCH, PhD, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01422122
- Sponsor's protocol ID
- 1479-Ped-ERC-10
- Other IDs
- Aga Khan University
- Acronym
- VitaminD
- Status last verified
- Apr 2017
- First submitted
- 21 Aug 2011
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 39077939Khan 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.
PubMed 31473727
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin D Supplementation on the Periodontal Health and Associated Outcomes in Pregnant Women
- ClinicalTrials.gov ID
- NCT01422122
- Acronym / sponsor ID
- VitaminD / 1479-Ped-ERC-10
- Keywords
- vitamin D, pregnancy, periodontal health, biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 23 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Vitamin D supplementation during pregnancy improves the periodontal health.
- There is an association between inflammatory biomarkers and periodontal health of pregnant females.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Experimental | Drug: Vitamin D3Oral vitamin D3 in syrup form |
| placebo | Placebo comparator | Drug: PlaceboPlacebo syrup identical in colour and taste to that of intervention |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3Also: Vitamin D, Cholecaciferol4000 mg per day, one tablespoon syrup per day | Drug | Vitamin D |
| PlaceboAlso: placebo syrupone table spoon Syrup per day | Drug | placebo |
Primary outcome
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)
1 secondary outcome
Interleukin 6 (IL-6) levels
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
- Derived from this study: PubMed 39077939Palacios 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.
- Derived from this study: PubMed 31473727Khan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zulfiqar A Bhutta, FRCPCH, PhD principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 in people with Gingival and Periodontal Disease and Deficiency of Vitamin D3, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periodontal Probing Depth (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01422122, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2017; AzTrials last refreshed its copy on 8 Nov 2026.