<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/NCT04469257</url>
  </required_header>
  <id_info>
    <org_study_id>123457</org_study_id>
    <nct_id>NCT04469257</nct_id>
  </id_info>
  <brief_title>SUN LIGHT EXPOSURE AND VITAMIN D LEVEL IN NURSING HOME</brief_title>
  <official_title>THE EFFECT OF SUN LIGHT EXPOSURE TO THE LEVEL OF VITAMIN D IN THE ELDERLY LIVING IN NURSING HOME</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tokat Gaziosmanpasa University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tokat Gaziosmanpasa University</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>
      Objective: The aim of the present study was to determine the effect of nursing interventions&#xD;
      and sunlight exposure to reach optimum vitamin D levels by individuals living in nursing&#xD;
      homes on vitamin D levels.&#xD;
&#xD;
      Material Method: In the first stage of this two-stage randomized-controlled experimental&#xD;
      study with pretest-posttest design conducted in June - August 2018 period in the nursing home&#xD;
      in Central Town of Tokat Province, the questionnaire prepared by the researcher, standardized&#xD;
      mini mental test, Fitzpatrick skin typing questionnaire and Katz Index of activities of daily&#xD;
      living were applied. Intervention (n=20) and control (n=20) groups were established with&#xD;
      individuals using simple random method according to age, gender, skin type and vitamin D&#xD;
      level. In the second stage, 30-35% of the body surface area of individuals in the&#xD;
      intervention group was exposed to sunlight five days a week in July. For the participants in&#xD;
      the control group, sunbathing was not offered. 25(OH)D, calcium, parathormone, phosphorus,&#xD;
      alkaline phosphatase and albumin levels of all individuals were measured in blood samples&#xD;
      taken at the beginning and end of the study. Two-way mixed ANOVA, Mann-Whitney U test,&#xD;
      Wilcoxon signed rank test and Chi-square tests were used to evaluate the data.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 27, 2018</start_date>
  <completion_date type="Actual">August 1, 2018</completion_date>
  <primary_completion_date type="Actual">August 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>pretest-posttest randomized controlled experimental study</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vitamin D</measure>
    <time_frame>5 week</time_frame>
    <description>Vitamin D Level</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Parathormone</measure>
    <time_frame>5 week</time_frame>
    <description>Parathormone level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Calicium</measure>
    <time_frame>5 week</time_frame>
    <description>Calcium Level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phosphorus</measure>
    <time_frame>5 week</time_frame>
    <description>Phosphorus level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alkaline Phosphatase</measure>
    <time_frame>5 week</time_frame>
    <description>Alkaline phosphatase level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Albumin</measure>
    <time_frame>5 week</time_frame>
    <description>Albumin level</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Nursing Home</condition>
  <condition>Vitamin D Deficiency</condition>
  <arm_group>
    <arm_group_label>Sunbathing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During the activities for the intervention group, the individuals were exposed directly to sun in the nursing home garden on open and sunny days without sunscreen for five days a week for a month with an average of 21.0 ± 5.0 min (min 15 min - max 30 min). About 30-35% of their bodies (hand, face, neck, forearm open up to elbows and legs open up to the knee caps) were open. Sunbathing sessions were held between 10:30 and 11:30 to prevent elderly individuals from being affected by extreme temperatures, and UV index values were monitored during the time and duration of the event at WHO website (http://www.who.int/uv/resources/link/indexlinks/en/, Access date: July 1, 2018). During the hours of the day when UV index was &gt; 6-7, elderly individuals were not taken out. After each sunbathing session, elderly individuals in the intervention group were evaluated for sensitivity and erythema that may occur in the exposed body areas</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Elderly individuals in the control group were not invited to the activities held in the nursing home garden. There were no restrictions on them for not going out in the sun or spending time inside the nursing home</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sunbathing</intervention_name>
    <description>the individuals were exposed directly to sun in the nursing home garden on open and sunny days without sunscreen for five days a week for a month with an average of 21.0 ± 5.0 min (min 15 min - max 30 min). About 30-35% of their bodies (hand, face, neck, forearm open up to elbows and legs open up to the knee caps) were open.</description>
    <arm_group_label>Sunbathing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  individuals (25 women and 41 men) who lived in nursing home during June 27, 2018 and&#xD;
             August 01, 2018 period&#xD;
&#xD;
          -  60 years and older&#xD;
&#xD;
          -  able to perform their daily life activities independently&#xD;
&#xD;
          -  agreed to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  malignancies&#xD;
&#xD;
          -  advanced liver and kidney failure&#xD;
&#xD;
          -  history of gastric-bowel operation&#xD;
&#xD;
          -  skin disease that could prevent sun exposure&#xD;
&#xD;
          -  hyperparathyroidism&#xD;
&#xD;
          -  malabsorption&#xD;
&#xD;
          -  use of drugs that affect the levels of vitamin D, calcium, PTH and phosphorus and&#xD;
             albumin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Tokat Gaziosmanpasa University</name>
      <address>
        <city>Tokat</city>
        <zip>60100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tokat Gaziosmanpasa University</investigator_affiliation>
    <investigator_full_name>Fatih OKAN</investigator_full_name>
    <investigator_title>LECTURER PHD.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D Deficiency</mesh_term>
  </condition_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/NCT04469257
org study id: 123457
nct id: NCT04469257
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Objective: The aim of the present study was to determine the effect of nursing interventions
      and sunlight exposure to reach optimum vitamin D levels by individuals living in nursing
      homes on vitamin D levels.

      Material Method: In the first stage of this two-stage randomized-controlled experimental
      study with pretest-posttest design conducted in June - August 2018 period in the nursing home
      in Central Town of Tokat Province, the questionnaire prepared by the researcher, standardized
      mini mental test, Fitzpatrick skin typing questionnaire and Katz Index of activities of daily
      living were applied. Intervention (n=20) and control (n=20) groups were established with
      individuals using simple random method according to age, gender, skin type and vitamin D
      level. In the second stage, 30-35% of the body surface area of individuals in the
      intervention group was exposed to sunlight five days a week in July. For the participants in
      the control group, sunbathing was not offered. 25(OH)D, calcium, parathormone, phosphorus,
      alkaline phosphatase and albumin levels of all individuals were measured in blood samples
      taken at the beginning and end of the study. Two-way mixed ANOVA, Mann-Whitney U test,
      Wilcoxon signed rank test and Chi-square tests were used to evaluate the data.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: pretest-posttest randomized controlled experimental study
primary purpose: Supportive Care
masking: None (Open Label)
measure: Vitamin D
time frame: 5 week
description: Vitamin D Level
measure: Parathormone
time frame: 5 week
description: Parathormone level
measure: Calicium
time frame: 5 week
description: Calcium Level
measure: Phosphorus
time frame: 5 week
description: Phosphorus level
measure: Alkaline Phosphatase
time frame: 5 week
description: Alkaline phosphatase level
measure: Albumin
time frame: 5 week
description: Albumin level
arm group label: Sunbathing
arm group type: Experimental
description: During the activities for the intervention group, the individuals were exposed directly to sun in the nursing home garden on open and sunny days without sunscreen for five days a week for a month with an average of 21.0 ± 5.0 min (min 15 min - max 30 min). About 30-35% of their bodies (hand, face, neck, forearm open up to elbows and legs open up to the knee caps) were open. Sunbathing sessions were held between 10:30 and 11:30 to prevent elderly individuals from being affected by extreme temperatures, and UV index values were monitored during the time and duration of the event at WHO website (http://www.who.int/uv/resources/link/indexlinks/en/, Access date: July 1, 2018). During the hours of the day when UV index was > 6-7, elderly individuals were not taken out. After each sunbathing session, elderly individuals in the intervention group were evaluated for sensitivity and erythema that may occur in the exposed body areas
arm group label: Control
arm group type: No Intervention
description: Elderly individuals in the control group were not invited to the activities held in the nursing home garden. There were no restrictions on them for not going out in the sun or spending time inside the nursing home
intervention type: Behavioral
intervention name: Sunbathing
description: the individuals were exposed directly to sun in the nursing home garden on open and sunny days without sunscreen for five days a week for a month with an average of 21.0 ± 5.0 min (min 15 min - max 30 min). About 30-35% of their bodies (hand, face, neck, forearm open up to elbows and legs open up to the knee caps) were open.
arm group label: Sunbathing
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Tokat Gaziosmanpasa University
investigator full name: Fatih OKAN
investigator title: LECTURER PHD.
mesh term: Vitamin D Deficiency
sharing ipd: No