<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03241381</url>
  </required_header>
  <id_info>
    <org_study_id>ECR/267/Indt/AP/2016</org_study_id>
    <nct_id>NCT03241381</nct_id>
  </id_info>
  <brief_title>Prevalence of Serum-Vitamin D Abnormalities, Periodontitis and Anaemia in Patients With Melasma</brief_title>
  <official_title>A Cross Sectional Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Panineeya Mahavidyalaya Institute of Dental Sciences &amp; Research Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Panineeya Mahavidyalaya Institute of Dental Sciences &amp; Research Centre</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Melasma is a commonly pigmention characterized by melanotic patches on the face. literature&#xD;
      searched revealed that periodontitis and vitamin D deficiency have occurred along with&#xD;
      anemia. Actinic associated factors may be indirectly related to vitamin D, melasma&#xD;
      contributes to sun exposed area of face.To correlate melasma with clinical evidence of&#xD;
      periodontitis and vitamin D serum analysis along side hb %. Patients with facial melasma&#xD;
      between 30-70yrs of either gender formed Group A (95). Anaemia and periodontitis were&#xD;
      Clinically checked. Additionally serum analysis of vitamin D and hb percentage were analysed.&#xD;
      Similar procedure was carried out on controls which had Group B (95) patients with no melasma&#xD;
      on face.&#xD;
&#xD;
      The study revealed significant correlation between melasma and periodontitis with vitamin D&#xD;
      abnormalities (p value&lt;.05), where as insignificant correlation between melasma and Hb%. The&#xD;
      correlation between melasma, vitamin d changes and periodontitis may prompt the clinician to&#xD;
      check for any such changes in any patient. Melasma in patients with periodontitis and serum&#xD;
      vitamin D changes might be a considered as a syndrome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Melasma, is a relatively common chronic pigmentation of the face, although it may be&#xD;
      localized also on the neck and forearms. It is also called as chloasma or mask of pregnancy.&#xD;
      It has higher prevalence in women and occurs less commonly in men. It most commonly affects&#xD;
      the sun-exposed areas of skin of face. Three patterns of presentation have been reported:&#xD;
      Centro-facial, malar and mandibular forms. The interplay of various risk factors are known to&#xD;
      contribute in the pathogenesis of melasma such as genetic predisposition, ultraviolet&#xD;
      radiation, hormonal factors, oral contraceptives and drugs like phenytoin. Thyroid&#xD;
      abnormalities were reported to occur with melasma. Skin pigmentation is a common&#xD;
      manifestation in nutritional deficiencies and frequently associated with deficiency of&#xD;
      vitamin B12 . Increased iron may affect the pattern and course of pigmentation, however it is&#xD;
      unclear how they coexist. Vitamin D3 (cholecalciferol) is synthesized from&#xD;
      7-dehydrocholesterol by photochemical process in the skin and through successive&#xD;
      hydroxylation to its active metabolite. 1, 25-dihydroxyvitamin D3 [1, 25(OH)2D3; calcitriol]&#xD;
      is formed in liver and kidney. Intracellular receptor (VDR) helps in binding of vitamin D&#xD;
      which helps the epithelial cells and melanocytes a target for vitamin D. Although vitamin D&#xD;
      is used in the treatment of melanoma and psoriasis and active role of 1, 25(OH)2D3 in skin no&#xD;
      reports of melasma associated with vitamin D reported. The dysfunction of 1,25(OH)2D3 - VDR&#xD;
      system may lead to periodontal disease . Mineral bone density could be directly related to&#xD;
      deficiency of vitamin D which also progress to osteoporosis. Studies have reported that&#xD;
      anemia may predispose to periodontitis but the correlation was not determined. Until date, no&#xD;
      studies reported any correlation or mere association between melasma, periodontitis and serum&#xD;
      vitamin D abnormalities as well as decreased Hb levels. The present study was intended to&#xD;
      assess the presence of periodontitis and vitamin D deficiency in melasma patients and&#xD;
      evaluate clinical presence of periodontitis, which may occur in conjunction with melasma and&#xD;
      vitamin D deficiency. The mere presence of melasma may help to investigate for further oral&#xD;
      issues such as periodontitis and anemia which may or may not be associated with vitamin D&#xD;
      abnormalities.&#xD;
&#xD;
      Patients visiting the Dept. of Oral medicine, with melasma on face within the age group of&#xD;
      30-70yrs in either gender were included in the study, matched with similar control group&#xD;
      without melasma after obtaining informed consent.&#xD;
&#xD;
      The patients were divided into 2 groups. Group A, had Patients with melasma in whom 2 ml of&#xD;
      blood was collected for estimation of serum-vitamin D levels, and complete blood picture was&#xD;
      estimated for Haemoglobin percentage and clinical oral examination was evaluated for&#xD;
      periodontitis. Group B served as control arm, where same procedure of blood parameter&#xD;
      estimation and clinical examination protocol was followed as in group A.&#xD;
&#xD;
      Total number of 100 patients participated in the study, 50 in each group. The samples that&#xD;
      resulted out of recruitment were tabulated and appropriate statistical analysis was done&#xD;
      comparing the both groups with the presence or absence of periodontitis and serum vitamin D&#xD;
      abnormalities and serum Hb% levels.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">August 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Serum Vitamin D analysis</measure>
    <time_frame>3 -4 days</time_frame>
    <description>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.&#xD;
&lt;12 ng/ml -significant deficiency 12- 20 ng/ml - insufficiency &gt;20 ng/ml - normal &gt; 50 ng/ml - hypervitaminosis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum- hemoglobin levels</measure>
    <time_frame>1 day</time_frame>
    <description>Evidence of pallor was checked clinically by examination of palpebral conjunctiva and correlated with serum haemoglobin percentage in both the groups using photometry method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Periodontal index</measure>
    <time_frame>1 day</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Melasma, Periodontitis, Vitamin D Abnormalities, Anaemia</condition>
  <arm_group>
    <arm_group_label>Group A : Melasma</arm_group_label>
    <description>patients with facial pigmentation in the form of melasma</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B: Non Melasma</arm_group_label>
    <description>Patients without any facial pigmentation or melasma</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>vitamin D serum assay study and control groups</intervention_name>
    <description>Serum- vitamin D assay</description>
    <arm_group_label>Group A : Melasma</arm_group_label>
    <arm_group_label>Group B: Non Melasma</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Photometry</intervention_name>
    <description>Serum- Hemoglobin assay</description>
    <arm_group_label>Group A : Melasma</arm_group_label>
    <arm_group_label>Group B: Non Melasma</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Russels periodontal index</intervention_name>
    <description>Clinical examination for periodontitis</description>
    <arm_group_label>Group A : Melasma</arm_group_label>
    <arm_group_label>Group B: Non Melasma</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Total number of 100 patients participated in the study, 50 in each group. Patients visiting&#xD;
        the Dept. of Oral medicine, with melasma on face within the age group of 30-70yrs in either&#xD;
        gender were included in the study, matched with similar control group without melasma after&#xD;
        obtaining informed consent.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The inclusion criteria were patients with history of melasma and who were willing to&#xD;
             be part of the study and patients who were not on any Systemic medication.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria included patients who were not willing to be part of the study,&#xD;
             patients who had endocrine disorders, patients with generalized pigmentation and as&#xD;
             well as patients on steroid therapy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>NALLAN Ck CHAITANYA, mds</last_name>
    <role>Principal Investigator</role>
    <affiliation>Panineeya Institute of dental sciences</affiliation>
  </overall_official>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>December 18, 2017</last_update_submitted>
  <last_update_submitted_qc>December 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Panineeya Mahavidyalaya Institute of Dental Sciences &amp; Research Centre</investigator_affiliation>
    <investigator_full_name>NALLAN CHAITANYA</investigator_full_name>
    <investigator_title>Associate Professor, department of oral medicine and radiology</investigator_title>
  </responsible_party>
  <keyword>observational sample</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
    <mesh_term>Anemia</mesh_term>
    <mesh_term>Congenital Abnormalities</mesh_term>
    <mesh_term>Melanosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03241381
org study id: ECR/267/Indt/AP/2016
nct id: NCT03241381
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Serum Vitamin D analysis
time frame: 3 -4 days
description: 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
measure: Serum- hemoglobin levels
time frame: 1 day
description: Evidence of pallor was checked clinically by examination of palpebral conjunctiva and correlated with serum haemoglobin percentage in both the groups using photometry method.
measure: Clinical Periodontal index
time frame: 1 day
description: 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.
arm group label: Group A : Melasma
description: patients with facial pigmentation in the form of melasma
arm group label: Group B: Non Melasma
description: Patients without any facial pigmentation or melasma
intervention type: Diagnostic Test
intervention name: vitamin D serum assay study and control groups
description: Serum- vitamin D assay
arm group label: Group A : Melasma
arm group label: Group B: Non Melasma
intervention type: Diagnostic Test
intervention name: Photometry
description: Serum- Hemoglobin assay
arm group label: Group A : Melasma
arm group label: Group B: Non Melasma
intervention type: Other
intervention name: Russels periodontal index
description: Clinical examination for periodontitis
arm group label: Group A : Melasma
arm group label: Group B: Non Melasma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: No
last name: NALLAN Ck CHAITANYA, mds
role: Principal Investigator
affiliation: Panineeya Institute of dental sciences
responsible party type: Principal Investigator
investigator affiliation: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
investigator full name: NALLAN CHAITANYA
investigator title: Associate Professor, department of oral medicine and radiology
mesh term: Periodontitis
mesh term: Anemia
mesh term: Congenital Abnormalities
mesh term: Melanosis
mesh term: Vitamin D
sharing ipd: No