drugset / Trial / NCT03951558

Comparison of the Impact of Diet vs Thiazide in BMD in Children With Idiopathic Hypercalciuria

NCT03951558

RandomizedParallel-groupSingle-blindPrevention

Summary

The investigator's objective is to compare and evaluate the impact of nutritional treatment vs. pharmacological treatment (hydrochlorothiazide) in bone mineral density in children with idiopathic hypercalciuria. A randomized, open-label, one-year follow-up study will be conducted in children aged 5 to 21 years with a confirmed diagnosis of idiopathic hypercalciuria or lithiasis, excluding those patients with secondary hypercalciuria (primary hyperoxaluria, treatment with vitamin D, Bartter syndrome, primary hyperparathyroidism), previous kidney transplantation. The impact of diet (hyposodic, calcium intake according to DIR for age, normal protein intake and high water intake) will be evaluated vs. the pharmacological treatment (hydrochlorothiazide) on bone mineral density.

Timeline

Start
2018-05-11
Primary completion
2019-06-30
Completion
2020-06-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Hydrochlorothiazide Unknown 0.5 mg/kg
Comparator Hydrochlorothiazide Unknown 1.5 mg/kg