An interventional study of Diet for calciuria prevention and Hydrochlorothiazide in Hypercalciuria; Idiopathic and Nephrolithiasis, sponsored by Hospital Infantil de Mexico Federico Gomez. Status unknown at 1 site in Mexico. Open to participants aged 5 Years to 21 Years. Per ClinicalTrials.gov, last updated 2019-05-15.
Sponsored by Hospital Infantil de Mexico Federico Gomez · Not applicable, Interventional, and Prevention
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:
33 studies on the registry are indexed under Hypercalciuria; 4 are open to participants now.
This study's planned enrollment of 90 is above the median of 40 across 25 interventional studies indexed under Hypercalciuria.
Browse Hypercalciuria studies →Hospital Infantil de Mexico Federico Gomez is the lead sponsor of 20 studies on the registry; 3 are open to participants now.
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placebo capsules and a strict eating 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.
Other: Diet for calciuria prevention
recommendations for water intake and decrease in salt intake will be given.
Drug: Hydrochlorothiazide
Dietary recommendations for water, salt, calcium and proteins according to age and DIR
Also known as: Diet for hypercalciuria
Hydroclorothiazide recommendations for hypercalciuria
Also known as: Hydroclorothiazide in hypercalciuria
bone mineral density
bone mineral density will be evaluated by means of score z evaluated by dexa
Time frame: one year
Ca/Cr index
urinary calcium excretion will be evaluated
Time frame: one year
Plan to share: Yes — a report of results will be made by means of a research article and information will be provided that researchers interested in the obtained data request
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: will be available at within one year
Access criteria: Requests for additional information will be reviewed by Nutriologa Ma Elena Ortiz and PhD. Mara Medeiros Domingo
No publications or documents are linked to this record.
Started May 2018 (actual). Primary completion is estimated for Jun 2019, 13 months after the start.
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This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Hospital Infantil de Mexico Federico Gomez