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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014041217234N1
Enrollment
50
Registered
2014-12-22
Start date
2013-10-23
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

nephrolythiasis. Calculus of kidney and ureter

Interventions

Intervention 1: 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-
contain 2 mEq/cc potassium) divided into three doses for three months. Intervention 2: In the control group, patients will receive 1-2 cc/kg potassium Polycitra (220 grams potassium citrate and 66 gra
contain 2 mEq/cc potassium) divided into three doses for three months.
Treatment - Drugs
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 potassiu
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

Sponsors

Vice chancellor for research, Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 14 Years

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

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

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNayereh Tousi

Mashhad University of Medical Science

dr.n.tousi@gmail.com+98 51 3764 6193

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026