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Evaluation of changes in urinary parameters after oral administration of magnesium chlorides and potassium citrate in pediatric with calcium oxalate urolithiasis.

Protocol summary

Summary
The objective of the present study is to investigate changes in urinary parameters after oral administration of magnesium chlorides and potassium citrate in pediatrics with calcium oxalate urolithiasis. In this interventional, semi-experimental, and prospective study, 30 patients, aged 1-18 years old, for whom the urinary tract stone diagnosis confirmed by the clinical symptoms or ultrasonography by a specialist, will be recruited. The patients will receive the potassium citrate solution for 4 weeks as the first phase and then solution of potassium citrate and chloride magnesium for another 4 weeks as the second phase. A sample of 24-hour urine and blood sample will be taken and calcium, potassium, Na, Cl, citrate, oxalate, Phosphate, creatinine, and magnesium will be checked before the study and after each phase and the results compared between the groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138707091282N1
Registration date: 2011-04-12, 1390/01/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-04-12, 1390/01/23
Registrant information
Name
Alaleh Gheissari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1250 2462
Email address
gheisari@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences and Health Services
Expected recruitment start date
2008-02-02, 1386/11/13
Expected recruitment end date
2011-01-01, 1389/10/11
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
Evaluation of changes in urinary parameters after oral administration of magnesium chlorides and potassium citrate in pediatric with calcium oxalate urolithiasis.
Public title
Evaluation of changes in urinary parameters after oral administration of magnesium chlorides and potassium citrate in pediatric with calcium oxalate urolithiasis.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age 2-12 years with possibility of calcium oxalate kidney stone, No past history of peptic ulcer, chronic diarrhea or cardiac disease, primary hyperparathyroidism, consumption of anticonvulsants, No proven history of disorders affecting tubular ion excretion such as: recent urinary tract infection , distal renal tubular acidosis , chronic pyelonephritis, renal dysfunction and obstructive uropathy Exclusion criteria: Patients who did not complete all steps of the study, refusing to consume either potassium citrate or magnesium chloride
Age
From 2 years old to 18 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences and Health Services
Street address
Isfahan University of Medical Sciences, Hezarjarib St., Isfahan
City
Isfahan
Postal code
Approval date
2008-08-20, 1387/05/30
Ethics committee reference number
286004

Health conditions studied

1

Description of health condition studied
urolithiasis
ICD-10 code
N20
ICD-10 code description
Calculus of kidney and ureter

Primary outcomes

1

Description
Urine parameter (Ca-K-Na-Cl-Cit-Ox-P-Cr-Mg)
Timepoint
Before and4 weeks after intervention
Method of measurement
24-hour urine test

2

Description
Blood parameter (Ca-K-Na-Cl-Cit-Ox-P-Cr-Mg)
Timepoint
Before and 4 weeks after intervention
Method of measurement
blood test

Secondary outcomes

empty

Intervention groups

1

Description
Phase 1: Oral solution of potassium citrate, 0.5 cc/kg/dose, every 8 hours, 30 min after meal, for 4 weeks
Category
Treatment - Drugs

2

Description
Phase 2: Combination of K Citrate 0.5 cc/kg/dose, every 8 hours, 30 min after meal as well as Mg Chloride 10-20 mg/kg/dose equivalent to 180 meq elemental Mg for 4 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan University of Medical Sciences
Full name of responsible person
Street address
Isfahan University of Medical Sciences, Hezarjarib St., Isfahan
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences and Health Services
Full name of responsible person
Dr Alaleh Gheisary
Street address
Isfahan University of Medical Sciences, Hezarjarib St., Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences and Health Services
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences and Health Services
Full name of responsible person
Dr Alaleh Gheisary
Position
Pediatric Dep., Isfahan University of Medical Sciences
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezarjarib St., Isfahan
City
Isfahan
Postal code
Phone
+98 913 313 3563
Fax
Email
gheisari@med.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences and Health Services
Full name of responsible person
Dr Alaleh Gheisary
Position
Pediatrics Nephrology Spacialist
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezarjarib St., Isfahan
City
Isfahan
Postal code
Phone
+98 913 313 3563
Fax
Email
gheisari@med.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences and Health Services
Full name of responsible person
Amin Ziaee
Position
MD student
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezarjarib St., Isfahan
City
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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