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

NCT03951558 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2019-05-15

No results posted yet for this study

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.

Conditions

  • Hypercalciuria; Idiopathic
  • Nephrolithiasis

Interventions

OTHER

Diet for calciuria prevention

Dietary recommendations for water, salt, calcium and proteins according to age and DIR

DRUG

Hydrochlorothiazide

Hydroclorothiazide recommendations for hypercalciuria

Sponsors & Collaborators

  • Hospital Infantil de Mexico Federico Gomez

    lead OTHER

Principal Investigators

  • Elena Ortiz, Master · Laboratorio de Enseñanza Virtual y Ciberpsicología. Facultad de Psicología. UNAM

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03951558 on ClinicalTrials.gov