Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03951558
Acronym
HIC
Enrollment
90
Registered
2019-05-15
Start date
2018-05-11
Completion date
2020-06-30
Last updated
2019-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercalciuria; Idiopathic, Nephrolithiasis

Keywords

diet, drinking water, salt, dietaryprotein

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)

Interventions

OTHERDiet for calciuria prevention

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

DRUGHydrochlorothiazide

Hydroclorothiazide recommendations for hypercalciuria

Sponsors

Hospital Infantil de Mexico Federico Gomez
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

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.

Eligibility

Sex/Gender
ALL
Age
5 Years to 21 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
bone mineral densityone yearbone mineral density will be evaluated by means of score z evaluated by dexa

Secondary

MeasureTime frameDescription
Ca/Cr indexone yearurinary calcium excretion will be evaluated

Countries

Mexico

Contacts

Primary ContactMa Elena Ortiz Cornejo, Master
meocnutricion@gmail.com(52) 01 55 5228 9917
Backup ContactMara Medeiros Domingo, PhD
(52) 01 55 5228 9917

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026