Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT03951558
Status:
UNKNOWN
Last Update Posted:
2019-05-15
First Post:
2019-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of the Impact of Diet vs Thiazide in BMD in Children With Idiopathic Hypercalciuria
Sponsor:
Hospital Infantil de Mexico Federico Gomez
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2019-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HIC
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.
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)
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: