Nephrolithiasis Clinical Trial
Official title:
Comparison of the Impact of Nutritional Treatment vs Hydrochlorothiazide on Bone Mineral Density and Body Composition in Children With Idiopathic Hypercalciuria of the Hospital Infantil de Méxio Federico Gómez
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.
A randomized, open-label clinical trial will be conducted with a one-year follow-up. For
which basal measurement of calciuria, citraturia, serum creatinine, serum and urinary
electrolytes, parathyroid hormone, vitamin D levels and renal ultrasound, as well as dietary
intake (protein, energy, salt and water). The dietary intake per day of food and
pharmacological treatment will be evaluated quarterly, body composition (anthropometry) and
serum and urinary electrolyte levels will be measured; Bone constitution (DXA, quantitative
bone ultrasound), IL-1 (as inflammatory markers) and vitamin D will be evaluated every six
months.
Participants will be blinded to the pharmacological treatment they will receive. The
randomization of the participants will be done through the page www.randomization.com. The
randomization was performed by blocks, where blocks of 6 members each were made i. Group 1:
only recommendations of water intake and reduction of salt intake and hydrochlorothiazide
will be given (the dose will be assigned according to weight and sex by a pediatric
nephrologist, dose of 0.5-1.5mg / kg / day, starting with the dose 1 mg / kg).
Hydrochlorothiazide will be provided to the patient.
ii. Group 2: placebo capsules and a strict diet plan will be given. The placebo will look
similar to that of hydrochlorothiazide and will be prepared in the Nephrology Research
Laboratory by Biol. Ana María Hernández Sánchez and Quim Lourdes Ortiz. The feeding plan will
be appropriate for the patient, it will consist of:
1. 40 ml / Kg / day of water
2. Protein according to age and sex
3. Recommendations for low sodium intake
4. Calcium according to age and sex (minimum 800mg)
;
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