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Comparing Effectiveness of combination of magnesium oxide and potassium citrate with potassium citrate in children with urolithiasis

Protocol summary

Summary
(1) Objectives: Comparing effectiveness of combination of magnesium oxide and potassium Polycitra with potassium Polycitra in children with urolithiasis. (2) Design: Patients will randomly be divided into intervention and control groups. Urinary and serum samples will be obtained and patients will receive treatment for three months. After three months, patients will be re-evaluated by sonography and biochemistry tests. (3) Setting and conduct: A random morning urine sample will be obtained in order to measure urinary citrate, uric acid and oxalate and a serum sample will be obtained in order to measure blood gases and serum calcium, creatinine, sodium, potassium and magnesium. Also, magnesium urinary level and urine specific gravity and pH will be checked at the beginning of study and at the time of radiological re-evaluation. (4) Participants including major eligibility criteria: All children with completed informed consent form and with diagnosis of urinary tract stone larger than 2 millimeter diameter will be included in the study. (5) Intervention: In the control group, patients will receive 1-2 cc/kg potassium Polycitra (220 grams potassium citrate and 66 grams citric acid which solute in 1000 cc distilled water; contain 2 mEq/cc potassium) divided into three doses and in intervention group, patients will receive daily single dose of magnesium oxide with recommended dietary allowance (RDA) in relation to patient's age and sex (30 to 410 mg/kg) and potassium Polycitra with the same dose as control group. (6) Main outcome measures (variables): Three months after initiating treatment, sonograpgy will be conducted on patients and they will be evaluated in terms of stone size changes (at least 1 mm) or stone resolution. Also a urine sample will be obtained to assess urine specific gravidity, pH, magnesium, calcium and creatinine in both groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014041217234N1
Registration date: 2014-12-22, 1393/10/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-12-22, 1393/10/01
Registrant information
Name
Nayereh Tousi
Name of organization / entity
Mashhad University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 51 3764 6193
Email address
tousin911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2013-10-23, 1392/08/01
Expected recruitment end date
2014-06-22, 1393/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing Effectiveness of combination of magnesium oxide and potassium citrate with potassium citrate in children with urolithiasis
Public title
Comparing Effectiveness of combination of magnesium oxide and potassium citrate with potassium citrate in children with urolithiasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All children: 1. Under 15 years of age with sonographic diagnosis of stone. 2. With stones greater than 2 mm diameter; Microlithiasis below 2 mm due to the possible technical errors and less clinical value will be ignored. 3. Who completed informed consent form. Exclusion criteria: 1. Presence of side effects (such as gastritis, gastrointestinal complications due to potassium citrate, sluggishness, lethargy, muscle weakness and diarrhea due to magnesium which drug would be discontinued in this case) 2. Comorbidities which influence tubular secretion such as renal tubular acidosis, pyelonephritis and obstructive uropathy. 3. Not referring in order to sonography and laboratory tests 4. Diagnosed cases who are under medication therapy 5. Over 15 years old age 6. Stones with 2 mm diameter or less 7. Patients need treatment other than conventional therapies such as patients who need hydrochlorothiazide or cystinuria patients who need penicillamine.
Age
To 14 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Danshgah St, Mashhad, Khorasan Razavi, Iran.
City
Mashhad
Postal code
Approval date
2013-12-21, 1392/09/30
Ethics committee reference number
920636

Health conditions studied

1

Description of health condition studied
nephrolythiasis
ICD-10 code
n20
ICD-10 code description
Calculus of kidney and ureter

Primary outcomes

1

Description
At least 1 millimeter change in stone size during treatment
Timepoint
First day and end of third month
Method of measurement
Sonography

Secondary outcomes

1

Description
Drug side effects such as gastritis and other GI complications due to potassium citrate and muscle weakness due to magnesium
Timepoint
Any time during study
Method of measurement
History and physical examination

Intervention groups

1

Description
In intervention group, patients will receive daily single dose of magnesium oxide with recommended dietary allowance (RDA) in relation to patient's age and sex (30 to 410 mg/kg) and 1-2 cc/kg potassium Polycitra (220 grams potassium citrate and 66 grams citric acid which solute in 1000 cc distilled water; contain 2 mEq/cc potassium) divided into three doses for three months.
Category
Treatment - Drugs

2

Description
In the control group, patients will receive 1-2 cc/kg potassium Polycitra (220 grams potassium citrate and 66 grams citric acid which solute in 1000 cc distilled water; contain 2 mEq/cc potassium) divided into three doses for three months.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr Sheikh Hospital, Pediatric Nephrology Department
Full name of responsible person
Nayereh Tousi
Street address
Dr Sheikh Hospital, Tohid Square, Motahari Avenue, Mashhad, Khorasan Razavi, Iran
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Daneshgah Street, Mashhad, Khorasan Razavi, Iran
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mashhad University of Medical Sciences
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
Mashhad University of Medical Science
Full name of responsible person
Nayereh Tousi
Position
Pediatric Resident
Other areas of specialty/work
Street address
No 169, Tofigh 15 Street, Shahid Sadeghi 10 Boulevard, Mashhad, Khorasan Razavi, Iran
City
Mashhad
Postal code
Phone
+98 51 3764 6193
Fax
Email
dr.n.tousi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Anoosh Azarfar
Position
Assistant professor
Other areas of specialty/work
Street address
Dr Sheikh Hospital, Tohid Square, Motahari Avenue, Mashhad, Khorasan Razavi, Iran.
City
Mashhad
Postal code
Phone
+98 51 3726 9021
Fax
Email
azarfara@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nayereh Tousi
Position
Pediatric resident
Other areas of specialty/work
Street address
No 169, Tofigh 15 Street, Shahid Sadeghi 10 Boulevard, Mashhad, Khorasan Razavi, Iran
City
Mashhad
Postal code
Phone
+98 51 3764 6193
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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