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Parathyroid Hormone (PTH) Homeostasis in Bartter Syndrome

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by Daniel Landau MD, Soroka University Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01021280
First Posted: November 26, 2009
Last Update Posted: June 14, 2012
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. Read our disclaimer for details.
Collaborator:
Ben-Gurion University of the Negev
Information provided by (Responsible Party):
Daniel Landau MD, Soroka University Medical Center
  Purpose

Parathyroid hormone (PTH) gland calcium sensing receptor (CASR) regulates PTH secretion. CASR is also expressed in nephron thick ascending limb (TAL). Bartter syndrome (BS), a normotensive hypokalemic tubulopathy, may be due to mutations in different TAL channels, including the potassium channel ROMK. Mutations in CASR may also cause BS through its effects on ROMK function. However, it is unknown whether ROMK mutations exert any effects on CASR function and PTH physiology. Preliminary data from our center shows that PTH levels were specifically elevated in type II (where ROMK is mutated) and not in type IV (where another gene, Barttin is defective) BS, without a common explanation. We assume that the mutation in ROMK may cause a dysregulation of PTH secretion via possible interaction with CASR.

The purpose of this study is: to investigate the PT-gland function and regulation in BS.

Methods: Patients with BS type II and IV and normal controls will undergo a standard protocol of controlled ionic hypo- and hypercalcemia, during which PTH secretion, phosphate balance and calcium excretion will be followed. Calcium Vs PTH response curves will be generated and compared.

Expected impact and benefit: the results of this study will help understand the mechanisms of PTH regulation beyond CASR.


Condition
Hypocalcemia Hypercalcemia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Case-control Study of the PTH Homeostasis in Adolescents and Young Adults With Bartter Syndrome

Resource links provided by NLM:


Further study details as provided by Daniel Landau MD, Soroka University Medical Center:

Biospecimen Retention:   Samples Without DNA
Serum and urine will be later analyzed for FGF-23 and other key molecules in PTH homeostasis.

Estimated Enrollment: 15
Study Start Date: January 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Type II BS
Adolescents and young adults with type II Bartter syndrome
Type IV BS
Adolescents and adults with type IV Bartter syndrome
Controls
Age and sex- matched controls

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adolescent and young adult patients with Bartter syndrome and age- and sex- matched controls.
Criteria

Inclusion Criteria:

  • Bartter syndrome
  • Normal Vitamin D status

Exclusion Criteria:

  • Age < 14 yrs
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01021280


Locations
Israel
Soroka University medical Center Not yet recruiting
Beer Sheva, Israel, 84101
Contact: Daniel Landau, MD    972-8-6400546    ldaniel@bgu.ac.il   
Contact: Ruth Schreiber, MD    972-8-6400546    ruthalon@rogers.com   
Principal Investigator: Daniel Landau, MD         
Sub-Investigator: Ruth Schreiber, MD         
Sponsors and Collaborators
Soroka University Medical Center
Ben-Gurion University of the Negev
  More Information

Responsible Party: Daniel Landau MD, Head, Pediatrics Department A and Pediatric Nephrology Service, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT01021280     History of Changes
Other Study ID Numbers: Sor492809ctil
First Submitted: November 25, 2009
First Posted: November 26, 2009
Last Update Posted: June 14, 2012
Last Verified: June 2012

Keywords provided by Daniel Landau MD, Soroka University Medical Center:
Bartter syndrome,
parathyroid hormone,
calcium sensing receptor,
ROMK channel
Barttin gene
PTH response to hypo- and hypercalcemia

Additional relevant MeSH terms:
Hypocalcemia
Hypercalcemia
Bartter Syndrome
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance
Renal Tubular Transport, Inborn Errors
Kidney Diseases
Urologic Diseases
Hyperaldosteronism
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases