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CompletedNCT00765531Updated May 3, 2024

Stone Disease in Children and Their Families

An observational study in Hypercalciuria and Urolithiasis, sponsored by University of Texas Southwestern Medical Center. Completed. Open to participants aged 4 Years to 20 Years. Per ClinicalTrials.gov, last updated 2024-05-03.

Sponsored by University of Texas Southwestern Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
15
Ages
4 Years to 20 Years
Sex
All
01

Study summary

The hypothesis of this study proposal is that pediatric urinary stone formers have genetic risk factors which predispose their urinary stone production. 50-60% of pediatric stone patients have a positive family history of urinary stone disease. Several genetic mutations have been identified which predispose patients to various types of urinary stones. These genetic mutations can also lead to other significant sequela besides stones, including osteopenia/osteoporosis (bone loss). Furthermore, metabolic abnormalities can be identified in more than 50% of pediatric stone formers, some of which can be improved and/or alleviated with medical intervention to help decrease rate of stone formation and the need for hospitalization and surgical intervention.

Read the detailed description

Although more frequent in adults, urolithiasis (urinary stones) is not rare in children, accounting for an estimated 1 in 7,600 hospital admissions. Recent reports have demonstrated a rising incidence of urinary stones in children. The hypothesis of this study proposal is that pediatric urinary stone formers have genetic risk factors which predispose their urinary stone production. 50-60% of pediatric stone patients have a positive family history of urinary stone disease. Several genetic mutations have been identified which predispose patients to various types of urinary stones. These genetic mutations can also lead to other significant sequela besides stones, including osteopenia/osteoporosis (bone loss). Furthermore, metabolic abnormalities can be identified in more than 50% of pediatric stone formers, some of which can be improved and/or alleviated with medical intervention to help decrease rate of stone formation and the need for hospitalization and surgical intervention.

Independent of age, calcium is the main crystalline constituent of kidney stones in up to 80% of cases and calcium oxalate stones are the most common stone type. At all ages, hypercalciuria (urinary calcium excretion >4 mg/kg/d or urinary calcium / urinary creatinine > 0.2) is the most common metabolic cause of urolithiasis. Hypercalciuria is a common metabolic abnormality among patients who form calcium oxalate stones. Hypercalciuria can be primary (absorptive or renal) or secondary (resorptive). Primary absorptive hypercalciuria is the result of an increase in intestinal calcium absorption while primary renal hypercalciuria occurs when the kidneys leak calcium. Laboratory tests, including a serum parathyroid hormone level and urinary calcium excretion before and after dietary calcium restriction or load, are required to define which type of hypercalciuria is occurring. Secondary hypercalciuria may be the result of excessive sodium intake or induced by certain drugs. More commonly, secondary hypercalciuria is associated with other diseases (such as hypercalcemia, distal renal tubular acidosis, hyperparathyroidism, hypocitraturia, hypophosphatasia, Bartter's syndrome or prolonged immobilization). Whatever the cause, proper diagnosis and management of hypercalciuria in children is important since 50% may develop nephrocalcinosis and urolithiasis. In addition, vertebral bone loss has been reported in 30% of hypercalciuric children. In our patients who have undergone metabolic testing to date, approximately 50% have evidence of hypercalciuria.

Hypercalciuria resulting from increased absorption of calcium from the gut, termed absorptive hypercalciuria (AH), accounts for 45% of all reported cases of stone formation. AH has long been suspected to be genetic. More than 40% of first degree relatives of patients with hypercalciuria also have a history of urolithiasis. Over the last 10 years, investigators have sought to understand the molecular basis of this presumed genetic observation. The genotypes of individuals with hypercalciuria have been studied trying to associate polymorphisms in the vitamin D receptor gene with nephrolithiasis, but it seems vitamin D genotype has no clear influence on this phenotype. However, recently, a new candidate-gene was identified by Gitomer, et al which was linked to AH in Caucasian adults; it was mapped to chromosome 1q24. This gene has been putatively identified as a gut-specific soluble isoform of an adenylate cyclase which when mutated causes absorptive hypercalciuria. Four polymorphisms and two mutations have thus far been described; the presence of any of these 4 individual base substitutions yielded a 2.2 to 3.5-fold increase in estimated risk for absorptive hypercalciuria. These base changes were also associated with decreased spinal bone density and the occurrence of osteoporosis in the AH population. The incidence of gene mutations in this newly described AH gene has not been reported in children with either hypercalciuria, calcium oxalate stones or a positive family history.

In addition, novel candidate genes causing urolithiasis may be discovered during the duration of this study which would become subjects of investigation. Similarly, pedigrees from stone-forming probands affected in childhood have not been studied for medical outcomes, stone recurrence risks, or for novel gene searches. Unique pediatric stone cases that have been seen at Children's Medical Center include:

  1. Xanthinuria (n=1)
  2. Primary Hyperoxaluria, type 1 (n=1)
  3. Cystinuria (n=3)
  4. Hypocitraturia
  5. Hyperoxaluria
  6. Novel contiguous gene deletion syndrome with calcium nephrolithiasis (n=1)
  7. Uric acid nephrolithiasis with metabolic syndrome (n=1)

Overall, although smaller numbers of affected patients are identified, the investigation of rare cases with a severe phenotype, which often first manifests in the pediatric population, may lead to a major disease discovery, as has been shown in many genetic diseases. Thus, we now broaden the scope of this research to include all pediatric stone-formers of all races and underlying metabolic and/or genetic abnormalities.

02

Conditions studied

  • Hypercalciuria
  • Urolithiasis

Keywords

  • Determine prevalence of genetic mutations in a population.
  • Identify stone formers w/significant family history.
  • follow a cohort of pediatric stone formers & their families.
  • Report long-term recurrence rates & therapeutic outcomes.
03

In context

Hypercalciuria

33 studies on the registry are indexed under Hypercalciuria; 4 are open to participants now.

Browse Hypercalciuria studies →

Lead sponsor

University of Texas Southwestern Medical Center is the lead sponsor of 1,010 studies on the registry; 199 are open to participants now.

Of its 139 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 20 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Individuals 4-20 years old of any sex with history of kidney stone formation and their family members.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male and female patients of all races with a history of stone formation before age 20 years, patients with a history of stone formation between the ages of 4 and 19 years will be included regardless of current age or gender, healthy family members (>4 years of age to 75 years) of the probands will be invited to participate in the study and will be characterized as an affected or unaffected patient by the testing, and sex- and age-matched pediatric normal volunteers will also be recruited as controls.

Exclusion criteria

Exclusion Criteria:

  • Patients will be excluded with voiding dysfunction or metabolic disorders including renal tubular acidosis, chronic renal insufficiency, intestinal malabsorption (inflammatory bowel disease, history of ileal resection or bladder augmentation, and cystic fibrosis), hyperparathyroidism, prolonged immobilization, vitamin D excess, hypercalcemia, hypophosphatasia, Bartter's syndrome, high dose therapy, prematurity, and chronic lasix use. Any child with a bleeding diathesis or who is will be excluded given the increased risks of drawing blood. Participants who have been on anti-seizure medication such as Topamax or other lithogenic drugs and anti-seizure medication will be excluded.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

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Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

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05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
15 participants (actual)
Patient registry
No

Groups and cohorts

  • Testing group 1 - Patients with hypercalciuria and their families

    7 day diet and 44hr inpatient testing

  • Testing group 2 - Patients with or without hypercalciuria and their families

    7 day diet and outpatient testing

06

What researchers measure

Primary outcomes

  1. Urine calcium-creatinine ratio

    Time frame: 44 hours

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00765531
Responsible party
Linda A Baker (Professor of Urology, Director of Pediatric Urology Research, University of Texas Southwestern Medical Center) — Principal investigator
First posted
Oct 3, 2008
Primary completion
Sep 26, 2022
Completion
Dec 5, 2022
Last update
May 3, 2024

Study contacts

Linda Baker, MD
principal investigator · Nationwide Children's Hospital
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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