Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 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 MarÃa Hernández Sánchez and Quim Lourdes Ortiz. The feeding plan will be appropriate for the patient, it will consist of:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 MarÃa Hernández Sánchez and Quim Lourdes Ortiz. |
|
| hydrochlorothiazide for calciuria prevention | Placebo Comparator | recommendations for water intake and decrease in salt intake will be given. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet for calciuria prevention | Other | Dietary recommendations for water, salt, calcium and proteins according to age and DIR |
|
| Measure | Description | Time Frame |
|---|---|---|
| bone mineral density | bone mineral density will be evaluated by means of score z evaluated by dexa | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Ca/Cr index | urinary calcium excretion will be evaluated | one year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ma Elena Ortiz Cornejo, Master | Contact | (52) 01 55 5228 9917 | 4410 | meocnutricion@gmail.com |
| Mara Medeiros Domingo, PhD | Contact | (52) 01 55 5228 9917 | 4410 |
| Name | Affiliation | Role |
|---|---|---|
| Elena Ortiz, Master | Laboratorio de Enseñanza Virtual y CiberpsicologÃa. Facultad de PsicologÃa. UNAM | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Mexico, Federico Gómez | Recruiting | México | México City | 06720 | Mexico |
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
will be available at within one year
Requests for additional information will be reviewed by Nutriologa Ma Elena Ortiz and PhD. Mara Medeiros Domingo
Not provided
Not provided
| ID | Term |
|---|---|
| D053565 | Hypercalciuria |
| D053040 | Nephrolithiasis |
| ID | Term |
|---|---|
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007674 | Kidney Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004032 | Diet |
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D002740 | Chlorothiazide |
Not provided
Not provided
Not provided
Not provided
Not provided
The capsules are the same color in the placebo group and the intervention group. The content of the capsules is similar in both groups.
| Hydrochlorothiazide | Drug | Hydroclorothiazide recommendations for hypercalciuria |
|
|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D052801 | Male Urogenital Diseases |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |