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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04469257
Other study ID # 123457
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 27, 2018
Est. completion date August 1, 2018

Study information

Verified date July 2020
Source Tokat Gaziosmanpasa University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date August 1, 2018
Est. primary completion date August 1, 2018
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Turkey Tokat Gaziosmanpasa University Tokat

Sponsors (1)

Lead Sponsor Collaborator
Tokat Gaziosmanpasa University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Vitamin D Vitamin D Level 5 week
Secondary Parathormone Parathormone level 5 week
Secondary Calicium Calcium Level 5 week
Secondary Phosphorus Phosphorus level 5 week
Secondary Alkaline Phosphatase Alkaline phosphatase level 5 week
Secondary Albumin Albumin level 5 week
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