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

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.

Study Overview

• Status: Unknown
• Conditions: Nephrolithiasis; Hypercalciuria; Idiopathic
• Intervention / Treatment: Other: Diet for calciuria prevention; Drug: Hydrochlorothiazide

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • México City
    • México, México City, Mexico, 06720
      • Recruiting
      • Children's Hospital of Mexico, Federico Gómez
      • Contact: Ma Elena Ortiz Cornejo, Master; Phone Number: 4410 (52) 01 55 5228 9917; Email: meocnutricion@gmail.com
      • Contact: Mara Medeiros Domingo, PhD; Phone Number: 4410 (52) 01 55 5228 9917

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Diet for calciuria prevention; Dietary recommendations for water, salt, calcium and proteins according to age and DIR; Other Names: Diet for hypercalciuria
Placebo Comparator: hydrochlorothiazide for calciuria prevention; recommendations for water intake and decrease in salt intake will be given.	Drug: Hydrochlorothiazide; Hydroclorothiazide recommendations for hypercalciuria; Other Names: Hydroclorothiazide in hypercalciuria

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bone mineral density	bone mineral density will be evaluated by means of score z evaluated by dexa	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ca/Cr index	urinary calcium excretion will be evaluated	one year

Collaborators and Investigators

• Sponsor: Hospital Infantil de Mexico Federico Gomez
• Investigators: Study Chair: Elena Ortiz, Master, Laboratorio de Enseñanza Virtual y Ciberpsicología. Facultad de Psicología. UNAM

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2018
• Primary Completion (Anticipated): June 30, 2019
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: May 10, 2019
• First Submitted That Met QC Criteria: May 14, 2019
• First Posted (Actual): May 15, 2019

Study Record Updates

• Last Update Posted (Actual): May 15, 2019
• Last Update Submitted That Met QC Criteria: May 14, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: diet; drinking water; salt; dietaryprotein
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Urological Manifestations; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Kidney Calculi; Nephrolithiasis; Hypercalciuria; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Sodium Chloride Symporter Inhibitors; Hydrochlorothiazide
• Other Study ID Numbers: HIM-2017-046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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
• IPD Sharing Time Frame: will be available at within one year
• IPD Sharing Access Criteria: Requests for additional information will be reviewed by Nutriologa Ma Elena Ortiz and PhD. Mara Medeiros Domingo
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No