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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: |
NCT03367338 |
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Date of registration:
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05/12/2017 |
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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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Low-Phosphate Diet and Fibroblast Growth Factor-23 Level
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Scientific title:
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The Effect of Low-Phosphate Diet on Fibroblast Growth Factor-23 Level in Patients Undergoing Hemodialysis |
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Date of first enrolment:
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January 3, 2018 |
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Target sample size:
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35 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03367338 |
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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: Crossover Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Wan-Chuan Tsai |
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Address:
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Telephone:
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Email:
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Affiliation:
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Far Eastern Memorial Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subjects with end-stage kidney disease undergoing thrice-weekly hemodialysis for more
than three months, the most recent serum phosphate level greater than 5.5 mg/dL or
between 3.5 and 5.5 mg/dL with regular phosphate binder use, and having adequate
dialysis (urea reduction ratio equal to or greater than 65%)
Exclusion Criteria:
- Subjects with serum albumin less than 2.5 g/dL, having psychiatric disorders, mental
retardation or poor adherence
Age minimum:
20 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Dietary Intervention
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Chronic Kidney Disease Requiring Chronic Dialysis
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Hyperphosphatemia
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Elevated Fibroblast Growth Factor-23
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Intervention(s)
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Other: Low-phosphate diet
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Primary Outcome(s)
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Difference in change-from-baseline intact FGF-23
[Time Frame: 2 days]
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Secondary Outcome(s)
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Difference in change-from-baseline intact parathyroid hormone
[Time Frame: 2 days]
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Difference in change-from-baseline serum phosphate
[Time Frame: 2 days]
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Difference in change-from-baseline C-terminal FGF23
[Time Frame: 2 days]
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Secondary ID(s)
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FEMH-IRB-106108-F
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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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