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

Nephrolithiasis Clinical Trial

— HIC  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03951558
• Other study ID #: HIM-2017-046
• Status: Recruiting
• Phase: N/A
• Start date: May 11, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: May 2019
• Source: Hospital Infantil de Mexico Federico Gomez
• Contact: Ma Elena Ortiz Cornejo, Master
• Phone: (52) 01 55 5228 9917
• Email: meocnutricion[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 21 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hypercalciuria
• Hypercalciuria; Idiopathic
• Kidney Calculi
• Nephrolithiasis

Intervention

Other:
• Diet for calciuria prevention
Dietary recommendations for water, salt, calcium and proteins according to age and DIR

Drug:
• Hydrochlorothiazide
Hydroclorothiazide recommendations for hypercalciuria

Locations

Country	Name	City	State
Mexico	Children's Hospital of Mexico, Federico Gómez	México	México City

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Infantil de Mexico Federico Gomez

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bone mineral density	bone mineral density will be evaluated by means of score z evaluated by dexa	one year
Secondary	Ca/Cr index	urinary calcium excretion will be evaluated	one year