Hypercalciuria; IdiopathicHICNCT03951558
Comparison of the Impact of Diet vs Thiazide in BMD in Children With Idiopathic Hypercalciuria
A study testing Diet for calciuria prevention and Hydrochlorothiazide in people with Hypercalciuria; Idiopathic and Nephrolithiasis, run by Hospital Infantil de Mexico Federico Gomez at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 5 to 21 years
- Conditions the study is for
- Hypercalciuria; Idiopathic, Nephrolithiasis
- What is being tested?
- Diet for calciuria prevention and Hydrochlorothiazide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteMexico
- Study dates
- 11 May 2018to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinical diagnosis of idiopathic hypercalciuria
- Man or women
- 5 to 21 years
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Mara Medeiros Domingo, PhD contact
Mexico1 site, 1 recruiting
- Recruiting
Children's Hospital of Mexico, Federico Gómez
México, México City, 06720
Ma Elena Ortiz Cornejo, Master, (52) 01 55 5228 9917 ext. 4410, meocnutricion@gmail.com
Mara Medeiros Domingo, PhD, (52) 01 55 5228 9917 ext. 4410
About this study
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
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.
Read the 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:
- 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)
- Conditions
- Hypercalciuria; Idiopathic, Nephrolithiasis
- Being tested
- Diet for calciuria prevention, Hydrochlorothiazide
- Keywords
- diet, drinking water, salt, dietaryprotein
- Medical subject headings
- Hypercalciuria, Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet for calciuria preventionOther
Also called Diet for hypercalciuria
Dietary recommendations for water, salt, calcium and proteins according to age and DIR
HydrochlorothiazideDrug
Also called Hydroclorothiazide in hypercalciuria
Hydroclorothiazide recommendations for hypercalciuria
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Diet for calciuria prevention |
| hydrochlorothiazide for calciuria prevention | Placebo comparator | recommendations for water intake and decrease in salt intake will be given. Receives: Drug: Hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone mineral density
bone mineral density will be evaluated by means of score z evaluated by dexa
Measured: one year
Secondary outcomes (1)
Ca/Cr index
urinary calcium excretion will be evaluated
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start11 May 2018
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypercalciuria; IdiopathicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Infantil de Mexico Federico Gomez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mara Medeiros, Hospital Infantil de Mexico Federico Gomez
- Investigators
- Elena Ortiz, Master, Study chair, Laboratorio de Enseñanza Virtual y Ciberpsicología. Facultad de Psicología. UNAM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03951558
- Sponsor's protocol ID
- HIM-2017-046
- Acronym
- HIC
- Status last verified
- May 2019
- First submitted
- 10 May 2019
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03951558
- Acronym / sponsor ID
- HIC / HIM-2017-046
- Conditions
- Hypercalciuria; Idiopathic, Nephrolithiasis
- Keywords
- diet, drinking water, salt, dietaryprotein
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hospital Infantil de Mexico Federico GomezUniversity, hospital or other
- Study start
- 11 May 2018 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 15 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet for calciuria prevention | Experimental | Other: Diet for calciuria preventionplacebo 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. |
| hydrochlorothiazide for calciuria prevention | Placebo comparator | Drug: Hydrochlorothiaziderecommendations for water intake and decrease in salt intake will be given. |
Who may qualify
- Ages
- 5 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of idiopathic hypercalciuria
- Man or women
- 5 to 21 years
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet for calciuria preventionAlso: Diet for hypercalciuriaDietary recommendations for water, salt, calcium and proteins according to age and DIR | Other | Diet for calciuria prevention |
| HydrochlorothiazideAlso: Hydroclorothiazide in hypercalciuriaHydroclorothiazide recommendations for hypercalciuria | Drug | hydrochlorothiazide for calciuria prevention |
Primary outcome
bone mineral density
Time frame: one year
bone mineral density will be evaluated by means of score z evaluated by dexa
1 secondary outcome
Ca/Cr index
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mara Medeiros Domingo, PhD contact
Elena Ortiz, Master study chair
Laboratorio de Enseñanza Virtual y Ciberpsicología. Facultad de Psicología. UNAM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet for calciuria prevention and Hydrochlorothiazide in people with Hypercalciuria; Idiopathic and Nephrolithiasis, run by Hospital Infantil de Mexico Federico Gomez at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ma Elena Ortiz Cornejo, Master ((52) 01 55 5228 9917 ext. 4410, meocnutricion@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone mineral density (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2019.