The Effectiveness and Safety of Calcium Carbonate in Chronic Kidney Disease With Normophosphatemia

June 7, 2018 updated by: Pringgodigdo Nugroho, MD, Indonesia University

The Effectiveness and Safety of Calcium Carbonate in Chronic Kidney Disease With Normophosphatemia: A Double Blind, Randomized Controlled Trial

Background: Patient with stage 3 or 4 chronic kidney disease (CKD) usually has normal level of serum phosphate, due to increased serum fibroblast growth factor-23 (FGF23) level that resulted in increased phosphate urine excretion. On the other hand, serum FGF23 elevation was related to CKD progression, vascular calcification, cardiomegaly, and mortality. This double blind, randomized controlled trial study was conducted to evaluate effectiveness and safety of calcium carbonate administration in stage 3 or 4 CKD patients with normophosphatemia.

Hypothesis: Calcium carbonate administration is effective and safe in chronic kidney disease (CKD) with normophosphatemia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cardiovascular disease is the most cause of mortality of chronic kidney disease (CKD) patients. As CKD progresses, the prevalence of cardiovascular disease also increased. Beside traditional cardiovascular risk factor that the investigators have known, some non-traditional cardiovascular risk factors were reported to be associated with cardiovascular disease in CKD patients, which one of them was increased level of fibroblast growth factor-23 (FGF23).[1,2]

FGF23 reduces production of 1,25-vitamin D3 and expression of sodium-phosphate cotransport, and also excretes phosphate through urine. In healthy and CKD population, increased phosphate level resulted in increased production of FGF23. Normophosphatemia state in early to moderate stage of CKD was reported due to body compensation by increasing the level of FGF23. On the other hand, increased serum FGF23 level was related to CKD progression, cardiomegaly, vascular calcification, and mortality.[1] There are several ways to prevent hyperphosphatemia, such as low phosphor intake, phosphate binder administration, and adequate dialysis.[3]

Phosphate binder was reported to give positive effects in CKD patients with hyperphosphatemia. Studies which investigated the use of phosphate binder in CKD patients with normophosphatemia to decrease FGF23 were still limited and the result was controversial.[1]

Therefore, this double blind, randomized controlled trial study investigated the effectiveness and safety of calcium carbonate in early to moderate CKD patients with normophosphatemia in lowering FGF23 levels. Study participant were randomized to receive calcium carbonate or placebo for 12 weeks. Before and after intervention, blood and urine sample were taken to examine serum FGF23, serum phosphate, urine phosphate, ionized calcium, serum calcium, urea, creatinine, estimated glomerular filtration rate (eGFR), and albumin. Effectiveness of calcium carbonate administration was indicated by serum FGF23, while safety was indicated by serum calcium.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • Dr. Cipto Mangunkusumo Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stage 3 or 4 chronic kidney disease patient that visit nephrology or endocrinology outpatient clinic of dr. Cipto Mangunkusumo Hospital
  • Normal level of serum phosphate
  • Agreed to join in this study

Exclusion Criteria:

  • Subjects with BMI < 18.5 kg/m2 or > 30 kg/m2
  • Consume drugs which may interfere bone mineral metabolism

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Calcium Carbonate
Calcium carbonate 3 x 500 mg was given to 23 study participants for 12 weeks
Drug: Calcium Carbonate
Calcium carbonate was obtained from Pharmacy Department, Faculty of Medicine, University of Indonesia. Subjects were randomized to receive calcium carbonate or placebo for 12 weeks.
Placebo Comparator: Placebo oral capsule
Placebo oral capsule 3 x 1 was given to 23 study participants for 12 weeks
Drug: Placebo oral capsule
Placebo oral capsule was also obtained from Pharmacy Department, Faculty of Medicine, University of Indonesia. Subjects were randomized to receive calcium carbonate or placebo for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Fibroblast Growth Factor 23 (FGF-23)
Time Frame: 12 weeks
Serum FGF23 (pg/ml) as cardiovascular risk factor in chronic kidney disease (CKD) was measured and compared between 2 groups before and after intervention
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Calcium Level
Time Frame: 12 weeks
Serum calcium level (mg/dl) was measured and compared between 2 groups before and after intervention
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Collaborators

Dr Cipto Mangunkusumo General Hospital

Investigators

  • Principal Investigator: Pringgodigdo Nugroho, MD, Indonesia University
  • Principal Investigator: Maruhum Bonar H. Marbun, MD, Indonesia University
  • Principal Investigator: Bella Yunita, MD, Indonesia University
  • Principal Investigator: Cindy Astrella, MD, BMedSci, Indonesia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2015

Primary Completion (Actual)

December 11, 2016

Study Completion (Actual)

December 11, 2016

Study Registration Dates

First Submitted

May 22, 2018

First Submitted That Met QC Criteria

June 7, 2018

First Posted (Actual)

June 8, 2018

Study Record Updates

Last Update Posted (Actual)

June 8, 2018

Last Update Submitted That Met QC Criteria

June 7, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 198/UN2.F1/ETIK/2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Kidney Diseases

Clinical Trials on Calcium Carbonate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe