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

NCT03951558 | Unknown DMC

• 1 other identifier: HIM-2017-046
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercalciuria; Idiopathic; Nephrolithiasis

Keywords

diet; drinking water; salt; dietaryprotein

Outcome Measures

Primary Outcomes (1)

• bone mineral density

  bone mineral density will be evaluated by means of score z evaluated by dexa

  one year

Secondary Outcomes (1)

• Ca/Cr index

  one year

Study Arms (2)

Diet for calciuria prevention

EXPERIMENTAL

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

hydrochlorothiazide for calciuria prevention

PLACEBO COMPARATOR

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

Drug: Hydrochlorothiazide

Interventions

Diet for calciuria prevention OTHER

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

Also known as: Diet for hypercalciuria

Diet for calciuria prevention

Hydrochlorothiazide DRUG

Hydroclorothiazide recommendations for hypercalciuria

Also known as: Hydroclorothiazide in hypercalciuria

hydrochlorothiazide for calciuria prevention

Eligibility Criteria

• Age: 5 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospital Infantil de Mexico Federico Gomez: lead

Study Sites (1)

Children's Hospital of Mexico, Federico Gómez

México, México City, 06720, Mexico

RECRUITING

MeSH Terms

Conditions

Hypercalciuria; Nephrolithiasis

Interventions

Diet; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Elena Ortiz, Master

  Laboratorio de Enseñanza Virtual y Ciberpsicología. Facultad de Psicología. UNAM

  STUDY CHAIR

Central Study Contacts

Ma Elena Ortiz Cornejo, Master

CONTACT

(52) 01 55 5228 9917; meocnutricion@gmail.com

Mara Medeiros Domingo, PhD

CONTACT

(52) 01 55 5228 9917

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The capsules are the same color in the placebo group and the intervention group. The content of the capsules is similar in both groups.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph D Mara Medeiros Domingo

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 15, 2019
• Study Start: May 11, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2020
• Last Updated: May 15, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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

Locations

ME (1)