Observation of the Effect of Vitamin D Supplementation on Chronic Course of Patients With Ulcerative Colitis Based on Vitamin D Receptor Fok I Gene Polymorphism
Observation of the Effect of Vitamin D Supplementation on Chronic Course of Patients With Ulcerative Colitis Based on Vitamin D Receptor Fok I Gene Polymorphism,a Prospective Cohort Study
Aims:Prospectively observe the effects of Vitamin D drops supplementation on the chronic course of ulcerative colitis patients, analyze whether the effect of Vitamin D drops on UC patients is affected by factors such as disease site, disease activity, treatment, etc.Exploring the relationship between Fok I gene polymorphism and the efficacy of vitamin D supplementation. Provide a certain theoretical basis for "precision treatment" for UC patients in the future.
Design：It is a prospective cohort study. Investigators include a total of 100 participants with UC according to the inclusion and exclusion criteria, and divide them into two groups to assess their initial disease activity and detect related indicators. At the same time，investigators detect the Fok I gene polymorphism in all participants.One group is given Vitamin D drops 400IU per day orally, and the control group do not intervene. Participants' disease activity is assessed at baseline and related indicators are determined. The disease activity is re-evaluated in the 3rd, 6th, 9th, and 12th months, and the serum indexes are re-evaluated.Investigators use statistical methods to analyze whether Vitamin D drops supplementation treatment can increase the serum 25 (OH) D level of UC participants, improve the condition of UC participants,relationship with Fok I gene polymorphism，and analyze the effects of Vitamin D drops on participants with UC is affected by factors such as disease site, disease activity, and treatment.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
- The research can be started only after approval by the Medical Ethics Committee of the Second Affiliated Hospital of Wenzhou Medical University.
- According to the "Consensus on Diagnosis and Treatment of Inflammatory Bowel Disease" formulated by the Beijing Conference in 2018 as a standard, patients with clear diagnosis of UC are collected.Other diagnostic criteria include Vitamin D deficiency (<= 20ng / ml). Exclusion criteria included pregnancy, breastfeeding, liver and kidney dysfunction, concurrent autoimmune diseases, and use of antiepileptic drugs or drugs metabolized by liver cytochrome P450 enzymes.
- Assess disease activity of UC participants based on the "Moya score".
- General information about participants with UC is collected.
- Detection of Fok I gene polymorphism using Snapshot technology.
- The level of serum 25 (OH) D of participants is detected.
- Serum C-reactive protein, erythrocyte sedimentation rate, albumin, calcium and phosphorus levels are measured.
- Develop a treatment plan for all participants.
- Participants are divided into two groups, one group is given oral Vitamin D drops 400IU/ d, and the other group do not intervene.
- The disease activity is re-evaluated in the 3rd, 6th, 9th, and 12th months, and the above serum indexes are re-evaluated.
Follow-up for 12 months. By comparing the above indicators, observe that in the Han population:
- Can Vitamin D drops supplementation increase serum 25 (OH) D levels in patients with UC?
- Can Vitamin D drops supplementation improve the condition of patients with UC?
- Whether Fok I gene polymorphism affect the efficacy of Vitamin D drops supplementation therapy?
- Whether the effects of Vitamin D drops on UC patients is affected by factors such as disease site, disease activity, treatment, etc ..
- Through statistical analysis, comprehensive analysis of the effectiveness and safety of Vitamin D drops supplementation in Han patients with UC, and its relationship with Fok I gene polymorphism, providing a theoretical basis for further "precise treatment" intervention in inflammatory bowel disease.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase temprana 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Zhejiang
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Wenzhou, Zhejiang, Porcelana
- SAHWenzhouMU
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Clearly diagnosed patients with UC
- Vitamin D deficiency (<= 20ng / ml)
Exclusion Criteria:
- Pregnancy, lactation
- Liver and kidney insufficiency
- Co-morbid with other autoimmune diseases
- Use antiepileptic drugs or drugs metabolized by liver cytochrome P450 enzymes
- Vitamin D level is normal or high
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: Control
El otro grupo no interfiere.
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Experimental: Gotas de vitamina D
A este grupo de pacientes se les va a suplementar con gotas de Vitamina D 400UI/d por vía oral.
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Vitamin D-deficient UC patients are divided into two groups, one group is given orally with Vitamin D drops 400IU / d, while the other group do not interfere.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Genotype frequency of vitamin D receptor single nucleotide polymorphisms in participants
Periodo de tiempo: 1 year
|
Genotype frequency of vitamin D receptor single nucleotide polymorphisms in participants can reflect whether it is related to the severity of the disease and how much relevance.
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1 year
|
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Serum 25 (OH) D level
Periodo de tiempo: 1year
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Because serum 25 (OH) D levels are relatively stable, they are considered the most reliable indicator of vitamin D status
|
1year
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
velocidad de sedimentación globular
Periodo de tiempo: 1 año
|
La VSG se puede utilizar para reflejar el grado de inflamación del cuerpo.
|
1 año
|
|
Blood calcium and phosphorus
Periodo de tiempo: 1year
|
Monitoring serum calcium and phosphorus levels to prevent toxic side effects.
|
1year
|
|
Concentration of C-reactive protein in participants
Periodo de tiempo: 1year
|
Concentration of C-reactive protein can be used to reflect the degree of inflammation in the human body.
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1year
|
Colaboradores e Investigadores
Investigadores
- Investigador principal: Jiang yi, PhD, Second Affiliated Hospital of Wenzhou Medical University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
- Enfermedades del Sistema Digestivo
- Procesos Patológicos
- Enfermedades Gastrointestinales
- Trastornos Nutricionales
- Gastroenteritis
- Enfermedades del Colon
- Enfermedades intestinales
- Avitaminosis
- Enfermedades por deficiencia
- Desnutrición
- Enfermedades inflamatorias del intestino
- Úlcera
- Deficiencia de vitamina D
- Colitis
- Colitis Ulcerativa
- Efectos fisiológicos de las drogas
- Micronutrientes
- Vitaminas
- Agentes de conservación de la densidad ósea
- Vitamina D
Otros números de identificación del estudio
- SAHoWMU-CR2017-01-121
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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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