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

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ClinicalTrials.gov Identifier: NCT03951558
Recruitment Status : Recruiting
First Posted : May 15, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Mara Medeiros, 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.


Condition or disease Intervention/treatment Phase
Hypercalciuria; Idiopathic Nephrolithiasis Other: Diet for calciuria prevention Drug: Hydrochlorothiazide Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: The capsules are the same color in the placebo group and the intervention group. The content of the capsules is similar in both groups.
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : May 11, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Hydroclorothiazide in hypercalciuria




Primary Outcome Measures :
  1. bone mineral density [ Time Frame: one year ]
    bone mineral density will be evaluated by means of score z evaluated by dexa


Secondary Outcome Measures :
  1. Ca/Cr index [ Time Frame: one year ]
    urinary calcium excretion will be evaluated



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03951558


Contacts
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Contact: Ma Elena Ortiz Cornejo, Master (52) 01 55 5228 9917 ext 4410 meocnutricion@gmail.com
Contact: Mara Medeiros Domingo, PhD (52) 01 55 5228 9917 ext 4410

Locations
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Mexico
Children's Hospital of Mexico, Federico Gómez Recruiting
México, México City, Mexico, 06720
Contact: Ma Elena Ortiz Cornejo, Master    (52) 01 55 5228 9917 ext 4410    meocnutricion@gmail.com   
Contact: Mara Medeiros Domingo, PhD    (52) 01 55 5228 9917 ext 4410      
Sponsors and Collaborators
Hospital Infantil de Mexico Federico Gomez
Investigators
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Study Chair: Elena Ortiz, Master UNAM

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Responsible Party: Mara Medeiros, Ph D Mara Medeiros Domingo, Hospital Infantil de Mexico Federico Gomez
ClinicalTrials.gov Identifier: NCT03951558     History of Changes
Other Study ID Numbers: HIM-2017-046
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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

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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
Keywords provided by Mara Medeiros, Hospital Infantil de Mexico Federico Gomez:
diet
drinking water
salt
dietaryprotein
Additional relevant MeSH terms:
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Hydrochlorothiazide
Nephrolithiasis
Kidney Calculi
Hypercalciuria
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical
Urological Manifestations
Signs and Symptoms
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action