- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04469257
SUN LIGHT EXPOSURE AND VITAMIN D LEVEL IN NURSING HOME
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
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Tokat, Kalkun, 60100
- Tokat Gaziosmanpasa University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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
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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.
|
|
Ingen indgriben: 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
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Vitamin D
Tidsramme: 5 week
|
Vitamin D Level
|
5 week
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Parathormone
Tidsramme: 5 week
|
Parathormone level
|
5 week
|
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Calicium
Tidsramme: 5 week
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Calcium Level
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5 week
|
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Phosphorus
Tidsramme: 5 week
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Phosphorus level
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5 week
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Alkaline Phosphatase
Tidsramme: 5 week
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Alkaline phosphatase level
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5 week
|
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Albumin
Tidsramme: 5 week
|
Albumin level
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5 week
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 123457
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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