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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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4 April 2022 |
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Main ID: |
NCT03984890 |
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Date of registration:
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05/12/2018 |
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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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Vitamin D3 For CGD Patients With BCGosis/Itis
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Scientific title:
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Effect of Vitamin D3 Supplementation on Chronic Granulomatous Disease Patients With BCGosis/Itis |
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Date of first enrolment:
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August 1, 2019 |
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Target sample size:
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50 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03984890 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2/Phase 3
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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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Weili Yan, Ph.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's Hospital of Fudan University |
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Name:
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Jinqiao Sun, Ph.D.,M.D |
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Address:
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Telephone:
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86-21-64932909 |
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Email:
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jinqiaosun@sina.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. less than 18 years' old
2. Diagnosed with CGD
3. Got BCG infection after vaccination
Exclusion Criteria:
1. Serum 25-(OH)-vit D >75 nmol/L (30 ng/mL)
2. Hyperphosphatemia
3. Hypercalcemia
4. Acute or chronic renal failure
5. Acute or chronic cardiac failure
6. Kidney stone
Age minimum:
N/A
Age maximum:
18 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Vitamin D3
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Chronic-granulomatous Disease
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BCG
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Intervention(s)
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Drug: Vitamin D3
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Drug: Traditional treatment of CGD and TB
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Primary Outcome(s)
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Urine Protein
[Time Frame: 8 weeks]
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Urine Calcium
[Time Frame: 8 weeks]
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Mortality
[Time Frame: 8 weeks]
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Duration of Fever
[Time Frame: 8 weeks]
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Number of Anti-tuberculosis Drugs Used in the Treatment
[Time Frame: 8 weeks]
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Serum Levels of 25-OH Vitamin D3
[Time Frame: 8 weeks]
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Rate of Sputum Culture acid-fast bacilli microscopy Conversion
[Time Frame: 8 weeks]
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Serum Levels of Calcium
[Time Frame: 8 weeks]
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Secondary Outcome(s)
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Change in BMI
[Time Frame: 1 year]
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Frequency of Recurrent Infections
[Time Frame: 1 year]
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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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