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A Cliniclal Study to find out the safest calcium supplement in calcium kidney stone formers

COMPARITIVE STUDY OF THE RISK OF CRYSTALURIA FOLLOWING ADMINISTRATION OF CALCIUM CARBONATE AND CALCIUM CITRATE MALLEATE IN CALCIUM OXALATE STONE FORMERS - CRCCCCCCO

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/04/018531
Enrollment
24
Registered
2019-04-10
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: N202- Calculus of kidney with calculus of ureter

Interventions

Intervention1: DOUBLE BLINDED CROSS OVER INTERVENTIONAL CLINICAL TRIAL â?¢ This crossover clinical trial is a repeated measures design study in which each patient is randomly assigned to a sequence o

Sponsors

State Board of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients who have been diagnosed as having calcium oxalate urinary stones 2.Between 15-65 years of age 3.With body mass index (BMI) between 18 and 30 kg/m2 4.willing to adhere to a low calcium diet for the duration of study (about 15 days)

Exclusion criteria

Exclusion criteria: 1.Patients with Obstructive Uropathy, Chronic Urosepsis / Positive Urine Culture, Renal failure, (S. Creatinine > 2.0 mg %) Renal Tubular Acidosis, Primary Hyperoxaluria, Medullary Sponge Kidney. 2.Patients with anatomical abnormalities of the Urinary Tracts 3.Have a serious alternate disease that might affect completion of the study or jeopardize the study, like a known medical history of calcium or vitamin D malabsorption, leading to hypercalcemia and hypercalciuria, any current or recent diagnosis thought to affect bone or mineral metabolism or parameters related to calcium bioavailability such as hypo- or hyperparathyroidism, hypothyroidism, dyslipidemia, liver disease, or diabetes mellitus. 4.Patients taking any medications like corticosteroids or proton pump inhibitors had any clinically significant illness within 30 days of the start of the study, 5.Pregnancy 6.Active cancer 7.Recurrent urinary infections 8.Gross hematuria 9.Receiving treatment with thiazides (or alternatively can be enrolled if the patient is willing to stop treatment for 2 weeks prior to study) 10.Inability to give informed consent

Design outcomes

Primary

MeasureTime frame
It is expected that Calcium Citrate Malleate will be a better calcium supplement than Calcium Carbonate in calcium oxalate stone formers.Timepoint: 2 weeks

Secondary

MeasureTime frame
The urine samples of the patients after drug administration should show optimum optical density values and risk for crystallisation.Timepoint: One, three and six months after starting therapy.

Countries

India

Contacts

Public ContactDrGSathish Kumar

GOVT. MEDICAL COLLEGE, THIRUVANANTHAPURAM

drgsatheeshkurup@gmail.com9446455385

Outcome results

None listed

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