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

Not Applicable

• Conditions: Hypercalciuria; Idiopathic; Nephrolithiasis
• Interventions: Other: Diet for calciuria prevention; Drug: Hydrochlorothiazide

• Registration Number: NCT03951558
• Lead Sponsor: Hospital Infantil de Mexico Federico Gomez

Brief 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.

Detailed Description

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)

Study Timeline

• Study Start: 2018-05-11
• Status Verified: 2019-05
• Study First Submitted: 2019-05-10
• Study First Submitted QC: 2019-05-14
• Last Update Submitted: 2019-05-14
• Study First Posted: 2019-05-15
• Last Update Posted: 2019-05-15
• Primary Completion: 2019-06-30
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Clinical diagnosis of idiopathic hypercalciuria
• Man or women
• 5 to 21 years

Exclusion Criteria

• Clinical diagnosis of secondary hypercalciuria (primary hyperoxaluria, treatment with vitamin D, Bartter syndrome, primary hyperparathyroidism)
• Previous kidney transplant
• Clinical diagnosis of kidney disease.
• Vitamin D intake (more than 800 mg/day)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diet for calciuria prevention	Diet for calciuria prevention	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.
hydrochlorothiazide for calciuria prevention	Hydrochlorothiazide	recommendations for water intake and decrease in salt intake will be given.

Primary Outcome Measures

Name	Time	Method
bone mineral density	one year	bone mineral density will be evaluated by means of score z evaluated by dexa

Secondary Outcome Measures

Name	Time	Method
Ca/Cr index	one year	urinary calcium excretion will be evaluated

Trial Locations

Locations (1)

Children's Hospital of Mexico, Federico Gómez; 🇲🇽 México, México City, Mexico