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SUN LIGHT EXPOSURE AND VITAMIN D LEVEL IN NURSING HOME

Primary Purpose

Nursing Home, Vitamin D Deficiency

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Sunbathing
Sponsored by
Tokat Gaziosmanpasa University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nursing Home

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • individuals (25 women and 41 men) who lived in nursing home during June 27, 2018 and August 01, 2018 period
  • 60 years and older
  • able to perform their daily life activities independently
  • agreed to participate in the study

Exclusion Criteria:

  • malignancies
  • advanced liver and kidney failure
  • history of gastric-bowel operation
  • skin disease that could prevent sun exposure
  • hyperparathyroidism
  • malabsorption
  • use of drugs that affect the levels of vitamin D, calcium, PTH and phosphorus and albumin

Sites / Locations

  • Tokat Gaziosmanpasa University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Sunbathing

Control

Arm 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

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

Outcomes

Primary Outcome Measures

Vitamin D
Vitamin D Level

Secondary Outcome Measures

Parathormone
Parathormone level
Calicium
Calcium Level
Phosphorus
Phosphorus level
Alkaline Phosphatase
Alkaline phosphatase level
Albumin
Albumin level

Full Information

First Posted
July 6, 2020
Last Updated
July 8, 2020
Sponsor
Tokat Gaziosmanpasa University
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1. Study Identification

Unique Protocol Identification Number
NCT04469257
Brief Title
SUN LIGHT EXPOSURE AND VITAMIN D LEVEL IN NURSING HOME
Official Title
THE EFFECT OF SUN LIGHT EXPOSURE TO THE LEVEL OF VITAMIN D IN THE ELDERLY LIVING IN NURSING HOME
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
June 27, 2018 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
August 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tokat Gaziosmanpasa University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nursing Home, Vitamin D Deficiency

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
pretest-posttest randomized controlled experimental study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sunbathing
Arm Type
Experimental
Arm 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 Title
Control
Arm Type
No Intervention
Arm 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(s)
Sunbathing
Intervention 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.
Primary Outcome Measure Information:
Title
Vitamin D
Description
Vitamin D Level
Time Frame
5 week
Secondary Outcome Measure Information:
Title
Parathormone
Description
Parathormone level
Time Frame
5 week
Title
Calicium
Description
Calcium Level
Time Frame
5 week
Title
Phosphorus
Description
Phosphorus level
Time Frame
5 week
Title
Alkaline Phosphatase
Description
Alkaline phosphatase level
Time Frame
5 week
Title
Albumin
Description
Albumin level
Time Frame
5 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: individuals (25 women and 41 men) who lived in nursing home during June 27, 2018 and August 01, 2018 period 60 years and older able to perform their daily life activities independently agreed to participate in the study Exclusion Criteria: malignancies advanced liver and kidney failure history of gastric-bowel operation skin disease that could prevent sun exposure hyperparathyroidism malabsorption use of drugs that affect the levels of vitamin D, calcium, PTH and phosphorus and albumin
Facility Information:
Facility Name
Tokat Gaziosmanpasa University
City
Tokat
ZIP/Postal Code
60100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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SUN LIGHT EXPOSURE AND VITAMIN D LEVEL IN NURSING HOME

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