Comparison of the Impact of Diet vs Thiazide in BMD in Children With Idiopathic Hypercalciuria (HIC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03951558|
Recruitment Status : Recruiting
First Posted : May 15, 2019
Last Update Posted : May 15, 2019
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|
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:
- 40 ml / Kg / day of water
- Protein according to age and sex
- Recommendations for low sodium intake
- Calcium according to age and sex (minimum 800mg)
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|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|
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.
Hydroclorothiazide recommendations for hypercalciuria
Other Name: Hydroclorothiazide in hypercalciuria
- bone mineral density [ Time Frame: one year ]bone mineral density will be evaluated by means of score z evaluated by dexa
- Ca/Cr index [ Time Frame: one year ]urinary calcium excretion will be evaluated
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03951558
|Contact: Ma Elena Ortiz Cornejo, Master||(52) 01 55 5228 9917 ext firstname.lastname@example.org|
|Contact: Mara Medeiros Domingo, PhD||(52) 01 55 5228 9917 ext 4410|
|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 email@example.com|
|Contact: Mara Medeiros Domingo, PhD (52) 01 55 5228 9917 ext 4410|
|Study Chair:||Elena Ortiz, Master||UNAM|