Melasma, Periodontitis, Vitamin D Abnormalities, AnaemiaNCT03241381
Prevalence of Serum-Vitamin D Abnormalities, Periodontitis and Anaemia in Patients With Melasma
An observational study of Melasma, Periodontitis, Vitamin D Abnormalities, Anaemia, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre.
Trial summary
Melasma is a commonly pigmention characterized by melanotic patches on the face. literature searched revealed that periodontitis and vitamin D deficiency have occurred along with anemia. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Melasma, Periodontitis, Vitamin D Abnormalities, Anaemia
- What is being tested?
- Photometry and Russels periodontal index
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Aug 2017
- Phase
- Observational
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Total number of 100 patients participated in the study, 50 in each group. Patients visiting the Dept. of Oral medicine, with melasma on face within the age group of 30-70yrs in either gender were included in the study, matched with similar control group without melasma after obtaining informed consent.
Who may be able to join
- The inclusion criteria were patients with history of melasma and who were willing to be part of the study and patients who were not on any Systemic medication.
Who cannot join
- Exclusion criteria included patients who were not willing to be part of the study, patients who had endocrine disorders, patients with generalized pigmentation and as well as patients on steroid therapy.
About this study
Official title: A Cross Sectional Observational Study
Melasma is a commonly pigmention characterized by melanotic patches on the face. literature searched revealed that periodontitis and vitamin D deficiency have occurred along with anemia. Actinic associated factors may be indirectly related to vitamin D, melasma contributes to sun exposed area of face.To correlate melasma with clinical evidence of periodontitis and vitamin D serum analysis along side hb %. Patients with facial melasma between 30-70yrs of either gender formed Group A (95). Anaemia and periodontitis were Clinically checked. Additionally serum analysis of vitamin D and hb percentage were analysed. Similar procedure was carried out on controls which had Group B (95) patients with no melasma on face.
The study revealed significant correlation between melasma and periodontitis with vitamin D abnormalities (p value<.05), where as insignificant correlation between melasma and Hb%. The correlation between melasma, vitamin d changes and periodontitis may prompt the clinician to check for any such changes in any patient. Melasma in patients with periodontitis and serum vitamin D changes might be a considered as a syndrome.
Read the detailed description
Melasma, is a relatively common chronic pigmentation of the face, although it may be localized also on the neck and forearms. It is also called as chloasma or mask of pregnancy. It has higher prevalence in women and occurs less commonly in men. It most commonly affects the sun-exposed areas of skin of face. Three patterns of presentation have been reported: Centro-facial, malar and mandibular forms. The interplay of various risk factors are known to contribute in the pathogenesis of melasma such as genetic predisposition, ultraviolet radiation, hormonal factors, oral contraceptives and drugs like phenytoin. Thyroid abnormalities were reported to occur with melasma. Skin pigmentation is a common manifestation in nutritional deficiencies and frequently associated with deficiency of vitamin B12 . Increased iron may affect the pattern and course of pigmentation, however it is unclear how they coexist. Vitamin D3 (cholecalciferol) is synthesized from 7-dehydrocholesterol by photochemical process in the skin and through successive hydroxylation to its active metabolite. 1, 25-dihydroxyvitamin D3 [1, 25(OH)2D3; calcitriol] is formed in liver and kidney. Intracellular receptor (VDR) helps in binding of vitamin D which helps the epithelial cells and melanocytes a target for vitamin D. Although vitamin D is used in the treatment of melanoma and psoriasis and active role of 1, 25(OH)2D3 in skin no reports of melasma associated with vitamin D reported. The dysfunction of 1,25(OH)2D3 - VDR system may lead to periodontal disease . Mineral bone density could be directly related to deficiency of vitamin D which also progress to osteoporosis. Studies have reported that anemia may predispose to periodontitis but the correlation was not determined. Until date, no studies reported any correlation or mere association between melasma, periodontitis and serum vitamin D abnormalities as well as decreased Hb levels. The present study was intended to assess the presence of periodontitis and vitamin D deficiency in melasma patients and evaluate clinical presence of periodontitis, which may occur in conjunction with melasma and vitamin D deficiency. The mere presence of melasma may help to investigate for further oral issues such as periodontitis and anemia which may or may not be associated with vitamin D abnormalities.
Patients visiting the Dept. of Oral medicine, with melasma on face within the age group of 30-70yrs in either gender were included in the study, matched with similar control group without melasma after obtaining informed consent.
The patients were divided into 2 groups. Group A, had Patients with melasma in whom 2 ml of blood was collected for estimation of serum-vitamin D levels, and complete blood picture was estimated for Haemoglobin percentage and clinical oral examination was evaluated for periodontitis. Group B served as control arm, where same procedure of blood parameter estimation and clinical examination protocol was followed as in group A.
Total number of 100 patients participated in the study, 50 in each group. The samples that resulted out of recruitment were tabulated and appropriate statistical analysis was done comparing the both groups with the presence or absence of periodontitis and serum vitamin D abnormalities and serum Hb% levels.
- Being tested
- vitamin D serum assay study and control groups, Photometry, Russels periodontal index
- Keywords
- observational sample
- Medical subject headings
- Melanosis, Periodontitis, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D serum assay study and control groupsDiagnostic test
Serum- vitamin D assay
PhotometryDiagnostic test
Serum- Hemoglobin assay
Russels periodontal indexOther
Clinical examination for periodontitis
| Study group | Role | What they receive |
|---|---|---|
| Group A : Melasma | patients with facial pigmentation in the form of melasma Receives: Diagnostic Test: vitamin D serum assay study and control groups; Diagnostic Test: Photometry; Other: Russels periodontal index | |
| Group B: Non Melasma | Patients without any facial pigmentation or melasma Receives: Diagnostic Test: vitamin D serum assay study and control groups; Diagnostic Test: Photometry; Other: Russels periodontal index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Vitamin D analysis
- The criteria for serum vitamin D analysis was followed which was laid by NATIONAL INSTITUTE OF HEALTH vitamin D fact sheet (2011) in both the groups using chemilumnescence method.
<12 ng/ml -significant deficiency 12- 20 ng/ml - insufficiency >20 ng/ml - normal > 50 ng/ml - hypervitaminosis
Measured: 3 -4 days
Serum- hemoglobin levels
Evidence of pallor was checked clinically by examination of palpebral conjunctiva and correlated with serum haemoglobin percentage in both the groups using photometry method.
Measured: 1 day
Clinical Periodontal index
The criteria to diagnose periodontitis clinically was followed by regulations laid down by Russell's periodontal index status , using mouth mirror and plain probe on all the gingival tissue circumscribing each tooth. It was assessed for gingival inflammation and periodontal involvement with loss of attachment. The evaluation was done by only one specialist.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study startOct 2016
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melasma, Periodontitis, Vitamin D Abnormalities, AnaemiaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NALLAN CHAITANYA, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
- Investigators
- NALLAN Ck CHAITANYA, mds, Principal investigator, Panineeya Institute of dental sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241381
- Sponsor's protocol ID
- ECR/267/Indt/AP/2016
- Status last verified
- Dec 2017
- First submitted
- 2 Aug 2017
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross Sectional Observational Study
- ClinicalTrials.gov ID
- NCT03241381
- Acronym / sponsor ID
- ECR/267/Indt/AP/2016
- Keywords
- observational sample
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research CentreUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 7 Aug 2017 (actual)
- 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.
Melasma is a commonly pigmention characterized by melanotic patches on the face. literature searched revealed that periodontitis and vitamin D deficiency have occurred along with anemia. Actinic associated factors may be indirectly related to vitamin D, melasma contributes to sun exposed area of face.To correlate melasma with clinical evidence of periodontitis and vitamin D serum analysis along side hb %. Patients with facial melasma between 30-70yrs of either gender formed Group A (95). Anaemia and periodontitis were Clinically checked. Additionally serum analysis of vitamin D and hb percentage were analysed. Similar procedure was carried out on controls which had Group B (95) patients with no melasma on face.
The study revealed significant correlation between melasma and periodontitis with vitamin D abnormalities (p value<.05), where as insignificant correlation between melasma and Hb%. The correlation between melasma, vitamin d changes and periodontitis may prompt the clinician to check for any such changes in any patient. Melasma in patients with periodontitis and serum vitamin D changes might be a considered as a syndrome.
Detailed description
Melasma, is a relatively common chronic pigmentation of the face, although it may be localized also on the neck and forearms. It is also called as chloasma or mask of pregnancy. It has higher prevalence in women and occurs less commonly in men. It most commonly affects the sun-exposed areas of skin of face. Three patterns of presentation have been reported: Centro-facial, malar and mandibular forms. The interplay of various risk factors are known to contribute in the pathogenesis of melasma such as genetic predisposition, ultraviolet radiation, hormonal factors, oral contraceptives and drugs like phenytoin. Thyroid abnormalities were reported to occur with melasma. Skin pigmentation is a common manifestation in nutritional deficiencies and frequently associated with deficiency of vitamin B12 . Increased iron may affect the pattern and course of pigmentation, however it is unclear how they coexist. Vitamin D3 (cholecalciferol) is synthesized from 7-dehydrocholesterol by photochemical process in the skin and through successive hydroxylation to its active metabolite. 1, 25-dihydroxyvitamin D3 [1, 25(OH)2D3; calcitriol] is formed in liver and kidney. Intracellular receptor (VDR) helps in binding of vitamin D which helps the epithelial cells and melanocytes a target for vitamin D. Although vitamin D is used in the treatment of melanoma and psoriasis and active role of 1, 25(OH)2D3 in skin no reports of melasma associated with vitamin D reported. The dysfunction of 1,25(OH)2D3 - VDR system may lead to periodontal disease . Mineral bone density could be directly related to deficiency of vitamin D which also progress to osteoporosis. Studies have reported that anemia may predispose to periodontitis but the correlation was not determined. Until date, no studies reported any correlation or mere association between melasma, periodontitis and serum vitamin D abnormalities as well as decreased Hb levels. The present study was intended to assess the presence of periodontitis and vitamin D deficiency in melasma patients and evaluate clinical presence of periodontitis, which may occur in conjunction with melasma and vitamin D deficiency. The mere presence of melasma may help to investigate for further oral issues such as periodontitis and anemia which may or may not be associated with vitamin D abnormalities.
Patients visiting the Dept. of Oral medicine, with melasma on face within the age group of 30-70yrs in either gender were included in the study, matched with similar control group without melasma after obtaining informed consent.
The patients were divided into 2 groups. Group A, had Patients with melasma in whom 2 ml of blood was collected for estimation of serum-vitamin D levels, and complete blood picture was estimated for Haemoglobin percentage and clinical oral examination was evaluated for periodontitis. Group B served as control arm, where same procedure of blood parameter estimation and clinical examination protocol was followed as in group A.
Total number of 100 patients participated in the study, 50 in each group. The samples that resulted out of recruitment were tabulated and appropriate statistical analysis was done comparing the both groups with the presence or absence of periodontitis and serum vitamin D abnormalities and serum Hb% levels.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A : Melasma | – | Diagnostic Test: vitamin D serum assay study and control groups, Diagnostic Test: Photometry, Other: Russels periodontal indexpatients with facial pigmentation in the form of melasma |
| Group B: Non Melasma | – | Diagnostic Test: vitamin D serum assay study and control groups, Diagnostic Test: Photometry, Other: Russels periodontal indexPatients without any facial pigmentation or melasma |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Total number of 100 patients participated in the study, 50 in each group. Patients visiting the Dept. of Oral medicine, with melasma on face within the age group of 30-70yrs in either gender were included in the study, matched with similar control group without melasma after obtaining informed consent.
Key inclusion criteria (1 listed)
- The inclusion criteria were patients with history of melasma and who were willing to be part of the study and patients who were not on any Systemic medication.
Key exclusion criteria (1 listed)
- Exclusion criteria included patients who were not willing to be part of the study, patients who had endocrine disorders, patients with generalized pigmentation and as well as patients on steroid therapy.
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 D serum assay study and control groupsSerum- vitamin D assay | Diagnostic test | Group A : Melasma, Group B: Non Melasma |
| PhotometrySerum- Hemoglobin assay | Diagnostic test | Group A : Melasma, Group B: Non Melasma |
| Russels periodontal indexClinical examination for periodontitis | Other | Group A : Melasma, Group B: Non Melasma |
Primary outcome
Serum Vitamin D analysis
Time frame: 3 -4 days
I. The criteria for serum vitamin D analysis was followed which was laid by NATIONAL INSTITUTE OF HEALTH vitamin D fact sheet (2011) in both the groups using chemilumnescence method. <12 ng/ml -significant deficiency 12- 20 ng/ml - insufficiency >20 ng/ml - normal > 50 ng/ml - hypervitaminosis
Serum- hemoglobin levels
Time frame: 1 day
Evidence of pallor was checked clinically by examination of palpebral conjunctiva and correlated with serum haemoglobin percentage in both the groups using photometry method.
Clinical Periodontal index
Time frame: 1 day
The criteria to diagnose periodontitis clinically was followed by regulations laid down by Russell's periodontal index status , using mouth mirror and plain probe on all the gingival tissue circumscribing each tooth. It was assessed for gingival inflammation and periodontal involvement with loss of attachment. The evaluation was done by only one specialist.
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 19 Dec 2017.
- Individual participant dataSharing planned: No
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.
NALLAN Ck CHAITANYA, mds principal investigator
Panineeya Institute of dental sciences
Questions about this trial
What is this clinical trial studying?
An observational study of Melasma, Periodontitis, Vitamin D Abnormalities, Anaemia, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre.
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 1 inclusion and 1 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 19 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Serum Vitamin D analysis (time frame: 3 -4 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2017.