The Effect of Diuretics on Mineral and Bone Disorder in Chronic Kidney Disease Patients
Primary Purpose
Secondary Hyperparathyroidism, Chronic Kidney Disease
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Hydrochlorothiazide
Furosemide
Sponsored by
About this trial
This is an interventional prevention trial for Secondary Hyperparathyroidism focused on measuring diuretics, furosemide, hydrochlorothiazide, CKD-MBD, HRpQCT, parathyroid hormone
Eligibility Criteria
Inclusion Criteria:
- Estimated Glomerular Filtration Rate (calculated by CKD-EPI) between 30 and 60 ml/min
Exclusion Criteria:
- Diabetes;
- chronic use of: steroid, bisphosphonates and calcium carbonate
Sites / Locations
- Hospital das ClinicasRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Furosemide
Hydrochlorothiazide
Arm Description
Use of Furosemide, 40mg (1 tablet) per day, over 12 months
Use of Hydrochlorothiazide, 25mg (1 tablet) per day, over 12 months
Outcomes
Primary Outcome Measures
Parathyroid hormone (PTH) level.
Bone metabolism
Secondary Outcome Measures
Full Information
NCT ID
NCT03082742
First Posted
February 27, 2017
Last Updated
October 25, 2017
Sponsor
University of Sao Paulo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03082742
Brief Title
The Effect of Diuretics on Mineral and Bone Disorder in Chronic Kidney Disease Patients
Official Title
The Effect of Thiazide and Loop Diuretic on Mineral and Bone Disorder in Chronic Kidney Disease Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2015 (Actual)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Chronic kidney disease (CKD) patients often have associated systemic hypertension due to volume retention, as one of the mechanisms, therefore the use of diuretics is widespread in this population. One of the major complications of CKD is mineral and bone metabolism disorder (CKD-MBD), which include changes in the levels of calcium, phosphorus, vitamin D deficiency, increased circulating levels of fibroblast growth factor (FGF-23) and parathyroid hormone (PTH). These alterations are responsible for fractures, cardiovascular disease and mortality among patients with CKD. According to diuretic mechanism of action, sometimes increasing serum calcium (in the case of furosemide), sometimes decreasing it (in the case of thiazide), it is expected that the serum calcium may be altered, even within the range of normality, with consequent impact on the levels of PTH. Although most studies have shown that the use of thiazide diuretics decreases the risk of fractures, some showed the opposite. Similarly, although most studies have shown increased risk of fracture in association to loop diuretics use, some have failed in demonstrated this outcome. Only one study, a cohort study in a population of CKD, showed that furosemide was directly related to increased calciuria and PTH levels and the use of thiazide, in turn, showed completely opposite effect. However, certain issues are still not completely solved, for example, the interference of renal function itself on calciuria. It is possible that calciuria is not a so simple explanation that justifies the PTH levels changes, as no correlation was seen between calciuria and PTH levels. Better understanding of the exact relationship between the use of diuretics and the impact on CKD-MBD may be an alternative intervention, easily accessible and relatively inexpensive. The purpose of this study is to evaluate the impact of diuretic, specifically hydrochlorothiazide and furosemide, on bone architecture and mineral metabolism.
Detailed Description
This is a prospective randomized study to test the effects of thiazide and furosemide in bone parameters, which will be assessed by peripheral micro-tomography at baseline and 12 months later. The role of calciuria in these possible changes will be tested.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hyperparathyroidism, Chronic Kidney Disease
Keywords
diuretics, furosemide, hydrochlorothiazide, CKD-MBD, HRpQCT, parathyroid hormone
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Furosemide
Arm Type
Active Comparator
Arm Description
Use of Furosemide, 40mg (1 tablet) per day, over 12 months
Arm Title
Hydrochlorothiazide
Arm Type
Active Comparator
Arm Description
Use of Hydrochlorothiazide, 25mg (1 tablet) per day, over 12 months
Intervention Type
Drug
Intervention Name(s)
Hydrochlorothiazide
Intervention Type
Drug
Intervention Name(s)
Furosemide
Primary Outcome Measure Information:
Title
Parathyroid hormone (PTH) level.
Description
Bone metabolism
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Estimated Glomerular Filtration Rate (calculated by CKD-EPI) between 30 and 60 ml/min
Exclusion Criteria:
Diabetes;
chronic use of: steroid, bisphosphonates and calcium carbonate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rosilene M Elias, M.D., Ph.D
Phone
+5511 26617167
Email
rosilenemotta@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosilene M Elias, M.D., Ph.D
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clinicas
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosilene M Elias, M.D, Ph.D
Phone
+5511 2661-7167
Email
rosilenemotta@hotmail.com
First Name & Middle Initial & Last Name & Degree
Rosilene M Elias, M.D., Ph.D
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Diuretics on Mineral and Bone Disorder in Chronic Kidney Disease Patients
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