- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Tokat, Pavo, 60100
- Tokat Gaziosmanpasa University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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
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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.
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Sin intervención: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Vitamin D
Periodo de tiempo: 5 week
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Vitamin D Level
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5 week
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Parathormone
Periodo de tiempo: 5 week
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Parathormone level
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5 week
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Calicium
Periodo de tiempo: 5 week
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Calcium Level
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5 week
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Phosphorus
Periodo de tiempo: 5 week
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Phosphorus level
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5 week
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Alkaline Phosphatase
Periodo de tiempo: 5 week
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Alkaline phosphatase level
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5 week
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Albumin
Periodo de tiempo: 5 week
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Albumin level
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5 week
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 123457
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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