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Trial record 77 of 123 for:    hypertension "vitamin d"

The Effect of Diuretics on Mineral and Bone Disorder in Chronic Kidney Disease Patients

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ClinicalTrials.gov Identifier: NCT03082742
Recruitment Status : Recruiting
First Posted : March 17, 2017
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

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.

Condition or disease Intervention/treatment Phase
Secondary Hyperparathyroidism Chronic Kidney Disease Drug: Hydrochlorothiazide Drug: Furosemide Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Thiazide and Loop Diuretic on Mineral and Bone Disorder in Chronic Kidney Disease Patients
Actual Study Start Date : August 1, 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Furosemide
Use of Furosemide, 40mg (1 tablet) per day, over 12 months
Drug: Furosemide
Active Comparator: Hydrochlorothiazide
Use of Hydrochlorothiazide, 25mg (1 tablet) per day, over 12 months
Drug: Hydrochlorothiazide



Primary Outcome Measures :
  1. Parathyroid hormone (PTH) level. [ Time Frame: 12 months ]
    Bone metabolism



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03082742


Contacts
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Contact: Rosilene M Elias, M.D., Ph.D +5511 26617167 rosilenemotta@hotmail.com

Locations
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Brazil
Hospital das Clinicas Recruiting
Sao Paulo, SP, Brazil, 05403-000
Contact: Rosilene M Elias, M.D, Ph.D    +5511 2661-7167    rosilenemotta@hotmail.com   
Principal Investigator: Rosilene M Elias, M.D., Ph.D         
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Rosilene M Elias, M.D., Ph.D University of Sao Paulo

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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT03082742     History of Changes
Other Study ID Numbers: Diuretics - CKD-MBD
First Posted: March 17, 2017    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Sao Paulo General Hospital:
diuretics
furosemide
hydrochlorothiazide
CKD-MBD
HRpQCT
parathyroid hormone

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Hyperparathyroidism
Hyperparathyroidism, Secondary
Bone Diseases
Urologic Diseases
Renal Insufficiency
Parathyroid Diseases
Endocrine System Diseases
Musculoskeletal Diseases
Hydrochlorothiazide
Furosemide
Diuretics
Antihypertensive Agents
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Potassium Chloride Symporter Inhibitors