MedTrace Logo

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

NCT03550534 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2018-06-08

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Kidney Diseases

Interventions

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.

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.

Sponsors & Collaborators

  • Dr Cipto Mangunkusumo General Hospital

    collaborator OTHER

  • Indonesia University

    lead OTHER

Principal Investigators

  • Pringgodigdo Nugroho, MD · Indonesia University

  • Maruhum Bonar H. Marbun, MD · Indonesia University

  • Bella Yunita, MD · Indonesia University

  • Cindy Astrella, MD, BMedSci · Indonesia University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-06
Primary Completion
2016-12-11
Completion
2016-12-11

Countries

  • Indonesia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03550534 on ClinicalTrials.gov