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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT04309058 |
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Date of registration:
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24/02/2020 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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March 2020 |
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Target sample size:
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100 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT04309058 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Early Phase 1
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Countries of recruitment
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China
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Contacts
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Name:
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Jiang yi, PhD |
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Address:
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Telephone:
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0086-13676715542 |
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Email:
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wzjiangyi@yeah.net |
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Affiliation:
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Name:
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Jiang yi, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Second Affiliated Hospital of Wenzhou Medical University |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Vitamin D Supplement
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Ulcerative Colitis
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Vitamin D Deficiency
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Intervention(s)
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Drug: Vitamin D drops
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Primary Outcome(s)
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Genotype frequency of vitamin D receptor single nucleotide polymorphisms in participants
[Time Frame: 1 year]
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Serum 25 (OH) D level
[Time Frame: 1year]
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Secondary Outcome(s)
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erythrocyte sedimentation rate
[Time Frame: 1year]
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Blood calcium and phosphorus
[Time Frame: 1year]
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Concentration of C-reactive protein in participants
[Time Frame: 1year]
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Secondary ID(s)
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SAHoWMU-CR2017-01-121
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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