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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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TCTR |
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Last refreshed on:
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1 April 2024 |
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Main ID: |
TCTR20150220001 |
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Date of registration:
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20/02/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of Calcium Carbonate for Reduction of Serum Fibroblast Growth Factor 23 (FGF 23) in Chronic Kidney Disease Stage 3
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Scientific title:
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Dietary Phosphorus Control versus Combination of Diet and Calcium Carbonate as Phosphate Binder Therapy for Reduction of Serum Fibroblast Growth Factor 23 (FGF 23) in Chronic Kidney Disease Stage 3 |
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Date of first enrolment:
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19/02/2014 |
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Target sample size:
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75 |
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Recruitment status: |
Recruiting |
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URL:
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https://www.thaiclinicaltrials.org/show/TCTR20150220001 |
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Study type:
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Interventional |
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Study design:
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Randomized
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Phase:
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Phase 4
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Kraiwiporn
Kiattisunthorn |
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Address:
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Division of Nephrology, Department of Medicine, Siriraj Hospital
10700
Bangkok
Thailand |
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Telephone:
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+6624198383 |
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Email:
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kraiwiporn.kia@mahidol.ac.th |
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Affiliation:
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Mahidol University |
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Key inclusion & exclusion criteria
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Inclusion criteria: Chronic kidney disease stage 3 defined by estimated GFR using CKD-EPI formula
Age >18 years old
FGF-23 > 100 RU/mL
Exclusion criteria: 1. Serum albumin corrected calcium > 9.6 mg/dL or serum phosphate > 4.5 mg/dL or intact PTH > 65 pg/mL
2. History of symptomatic hypocalcemia
3. History of calculi in genitourinary system
4. Primary hyperparathyroidism
5. History of thyroidectomy, parathyroidectomy, or radiation of head and neck
6. Patients prescribed drugs interfering vitamin D and/or bone metabolism, for example, corticosteroids, phenytoin, calcimimetics, calcineurin inhibitor, etc.
6. Patients diagnosed osteoporosis and treated with bislphosphonates and/ or estrogen derivatives
7. Pregnancy
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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chronic kidney disease stage 3
calcium carbonate
phosphate binder
Fibroblast growth factor 23
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Chronic kidney disease stage 3
chronic kidney disease stage 3
calcium carbonate
phosphate binder
Fibroblast growth factor 23
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Intervention(s)
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Calcium carbonate 350 mg orally thice a day with meal plus phosphate diet restriction,Calcium carbonate 700 mg orally thrice a day with meal plus diet phosphate restriction,Diet phosphate restriction
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Calcium carbonate 350 mg,Calcium carbonate 700 mg,Placebo
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Experimental Drug,Experimental Drug,Placebo Comparator Behavioral
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Primary Outcome(s)
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FGF23 9 months pg/mL by Human FGF-23 (C-Term) ELISA Kit (Immunotopic, CA, USA)
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Secondary Outcome(s)
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hypercalcemia 9 months mg/dL
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Secondary ID(s)
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RO15632022
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Source(s) of Monetary Support
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Faculty of Siriraj Medicine Hospital
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Ethics review
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Status: Submitted, approved
Approval date:
Contact:
sarawut.nam@mahidol.ac.th
Siriraj Institutional Review Board (SIRB)
+66 2419 7000 Ext. 2667-72
sarawut.nam@mahidol.ac.th
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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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19/02/2016 |
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URL:
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