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临床试验/NCT03951558
NCT03951558Unknown不适用

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

Hospital Infantil de Mexico Federico Gomez1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年5月11日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
90
试验地点
1
主要终点
bone mineral density

研究概览

简要总结

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.

详细描述

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)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

The capsules are the same color in the placebo group and the intervention group. The content of the capsules is similar in both groups.

入排标准

年龄范围
5 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of idiopathic hypercalciuria
  • Man or women
  • 5 to 21 years

排除标准

  • 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)

研究组 & 干预措施

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 María Hernández Sánchez and Quim Lourdes Ortiz.

干预措施: Diet for calciuria prevention (Other)

hydrochlorothiazide for calciuria prevention

Placebo Comparator

recommendations for water intake and decrease in salt intake will be given.

干预措施: Hydrochlorothiazide (Drug)

结局指标

主要结局

bone mineral density

时间窗: one year

bone mineral density will be evaluated by means of score z evaluated by dexa

次要结局

  • Ca/Cr index(one year)

研究者

发起方
Hospital Infantil de Mexico Federico Gomez
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mara Medeiros

Ph D Mara Medeiros Domingo

Hospital Infantil de Mexico Federico Gomez

研究点 (1)

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