Evaluation of vitamin D deficiency treatment in patients with calcium kidney stones

Phase 3

Recruiting

• Conditions: Condition 1: Recurrent calcium stone formers. Condition 2: Vitamin D deficiency.; Calculus of kidney; Vitamin D deficiency; N20.0

• Registration Number: IRCT20160206026406N4
• Lead Sponsor: rology and nephrology research center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 October 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Serum vitamin D 10-20 ng/ml
body mass index under 30
Willingness to cooperate in the study

Exclusion Criteria

Known Cystine or Struvite kidney stones
Hypercalcemia
24-Hour urine calcium higher than 300 mg / 24h
Stone pass or gross hematuria in the last 2 months
New prescription or changing the dose of thiazide drugs or any drug that has an effect on calcium metabolism
Taking antiepileptic or glucocorticoid drugs or any medication that has an effect on vitamin D absorption.
Any history of the following diseases: hepatic diseases, diabetes mellitus, thyroid diseases, hyperparathyroidism, immunological diseases, cancers, chronic diarrhea, chronic kidney diseases, urinary tract infection, fat malabsorption, celiac disease, cystic fibrosis.
Pregnancy and lactation

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
24-hour urine calcium level. Timepoint: Before the intervention and 3 months later. Method of measurement: Colorimetry.;Serum vitamin D. Timepoint: Before the intervention and 3 months later. Method of measurement: ELISA.;Serum and urine Malondialdehyde. Timepoint: Before the intervention and 3 months later. Method of measurement: Colorimetry.;Serum and urine total antioxidant capacity. Timepoint: Before the intervention and 3 months later. Method of measurement: Colorimetry.

Secondary Outcome Measures

Name	Time	Method
Serum PTH level. Timepoint: Before the intervention and 3 months later. Method of measurement: ELISA.;Serum calcium. Timepoint: Before the intervention and 3 months later. Method of measurement: Colorimetry.;24 hour urine creatinine. Timepoint: Before the intervention and 3 months later. Method of measurement: Colorimetry.;24 hour urine urea. Timepoint: Before the intervention and 3 months later. Method of measurement: Colorimetry.;24 hour urine sodium. Timepoint: Before the intervention and 3 months later. Method of measurement: Ion-selective electrode potentiometry (ISE).;Calcium oxalate supersaturation. Timepoint: Before the intervention and 3 months later. Method of measurement: Calculated by LITHORISK software.;Calcium phosphate supersaturation. Timepoint: Before the intervention and 3 months later. Method of measurement: Calculated by LITHORISK software.