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Trial record 4 of 109 for:    CALCIUM CATION

Oral Peptones Load in Normocalcemic and Hypercalcemic Primary Hyperparathyroidism and Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01042626
Recruitment Status : Completed
First Posted : January 5, 2010
Last Update Posted : January 5, 2010
Sponsor:
Collaborator:
University of Milan
Information provided by:
University of Eastern Piedmont

Brief Summary:

The purpose of this study is to assess if subjects with hyperparathyroidism with normal serum calcium levels have different responses in the calcium regulating hormonal handling compared to a) patients with primary hyperparathyroidism and high serum calcium levels; b) healthy subjects.

The differences will be evaluated with oral peptones load and subsequent blood samples collected every 15 minutes for two hours. Ionized calcium, phosphate, gastrin and PTH levels will be evaluated.


Condition or disease Intervention/treatment Phase
Hyperparathyroidism Hypercalcemia Other: Oral peptones load Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Dissimilar PTH, Gastrin, and Ionized Calcium Response to Oral Peptones in Normocalcemic Primary Hyperparathyroidism, Hypercalcemic Primary Hyperparathyroidism and Healthy Subjects
Study Start Date : July 2004
Actual Primary Completion Date : January 2005
Actual Study Completion Date : January 2005


Arm Intervention/treatment
Experimental: Normocalcemic Hyperparathyroidism Other: Oral peptones load
Enrolled subjects will receive 10 g Liebig meat extract diluted in 250ml of 0.9% saline

Experimental: Hypercalcemic Hyperparathyroidism Other: Oral peptones load
Enrolled subjects will receive 10 g Liebig meat extract diluted in 250ml of 0.9% saline

Active Comparator: Healthy subjects Other: Oral peptones load
Enrolled subjects will receive 10 g Liebig meat extract diluted in 250ml of 0.9% saline




Primary Outcome Measures :
  1. PTH levels variations [ Time Frame: 2 hours ]
  2. Ionized serum calcium variations [ Time Frame: 2 hours ]
  3. Serum phosphate variations [ Time Frame: 2 hours ]
  4. Serum gastrin variations [ Time Frame: 2 hours ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. normocalcemic hyperparathyroidism

    • presence of high serum levels of intact PTH
    • serum ionized calcium levels in the high normality range
  2. hypercalcemic hyperparathyroidism

    • presence of high serum levels of intact PTH
    • high serum ionized calcium levels

Exclusion Criteria:

  1. potential causes of secondary hyperparathyroidism like renal insufficiency, liver disease, malabsorption, hypercalciuria, Paget's disease, thiazide diuretic or lithium use.
  2. bone disease of any origin

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): NCT01042626


Locations
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Italy
L. Sacco Hospital (Vialba)
Milano, MI, Italy, 20157
Sponsors and Collaborators
University of Eastern Piedmont
University of Milan

Publications:
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Responsible Party: Maurizio Bevilacqua, L. Sacco Hospital (Vialba)
ClinicalTrials.gov Identifier: NCT01042626     History of Changes
Other Study ID Numbers: NO012010
First Posted: January 5, 2010    Key Record Dates
Last Update Posted: January 5, 2010
Last Verified: January 2010
Keywords provided by University of Eastern Piedmont:
Receptors, Calcium sensing
Parathyroid Hormone
Additional relevant MeSH terms:
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Calcium Metabolism Disorders
Calcium
Calcium-Regulating Hormones and Agents
Hypercalcemia
Hyperparathyroidism
Hyperparathyroidism, Primary
Parathyroid Diseases
Endocrine System Diseases
Metabolic Diseases
Water-Electrolyte Imbalance
Physiological Effects of Drugs