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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-11

Study Completion Date

2020-06-30

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Hypercalciuria; Idiopathic Nephrolithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

The capsules are the same color in the placebo group and the intervention group. The content of the capsules is similar in both groups.

Study Groups

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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.

Group Type EXPERIMENTAL

Diet for calciuria prevention

Intervention Type OTHER

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

hydrochlorothiazide for calciuria prevention

recommendations for water intake and decrease in salt intake will be given.

Group Type PLACEBO_COMPARATOR

Hydrochlorothiazide

Intervention Type DRUG

Hydroclorothiazide recommendations for hypercalciuria

Interventions

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Diet for calciuria prevention

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

Intervention Type OTHER

Hydrochlorothiazide

Hydroclorothiazide recommendations for hypercalciuria

Intervention Type DRUG

Other Intervention Names

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Diet for hypercalciuria Hydroclorothiazide in hypercalciuria

Eligibility Criteria

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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)

Minimum Eligible Age

5 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No