SUN LIGHT EXPOSURE AND VITAMIN D LEVEL IN NURSING HOME

July 8, 2020 updated by: Fatih OKAN, Tokat Gaziosmanpasa University

THE EFFECT OF SUN LIGHT EXPOSURE TO THE LEVEL OF VITAMIN D IN THE ELDERLY LIVING IN NURSING HOME

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Tokat, Turkey, 60100
        • Tokat Gaziosmanpasa University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sunbathing
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
Behavioral: Sunbathing
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.
No Intervention: Control
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Vitamin D
Time Frame: 5 week
Vitamin D Level
5 week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Parathormone
Time Frame: 5 week
Parathormone level
5 week
Calicium
Time Frame: 5 week
Calcium Level
5 week
Phosphorus
Time Frame: 5 week
Phosphorus level
5 week
Alkaline Phosphatase
Time Frame: 5 week
Alkaline phosphatase level
5 week
Albumin
Time Frame: 5 week
Albumin level
5 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tokat Gaziosmanpasa University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 27, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 123457

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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