NCT04469257

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 27, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 14, 2020

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

1 month

First QC Date

July 6, 2020

Last Update Submit

July 8, 2020

Conditions

Nursing HomeVitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

  • Vitamin D

    Vitamin D Level

    5 week

Secondary Outcomes (5)

  • Parathormone

    5 week

  • Calicium

    5 week

  • Phosphorus

    5 week

  • Alkaline Phosphatase

    5 week

  • Albumin

    5 week

Study Arms (2)

Sunbathing

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

SunbathingBEHAVIORAL

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

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokat Gaziosmanpasa University

Tokat Province, 60100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: pretest-posttest randomized controlled experimental study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
LECTURER PHD.

Study Record Dates

First Submitted

July 6, 2020

First Posted

July 14, 2020

Study Start

June 27, 2018

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

July 14, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)