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

January 4, 2010 updated by: University of Eastern Piedmont

Dissimilar PTH, Gastrin, and Ionized Calcium Response to Oral Peptones in Normocalcemic Primary Hyperparathyroidism, Hypercalcemic Primary Hyperparathyroidism and Healthy Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • MI
      • Milano, MI, Italy, 20157
        • L. Sacco Hospital (Vialba)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PTH levels variations
Time Frame: 2 hours
2 hours
Ionized serum calcium variations
Time Frame: 2 hours
2 hours
Serum phosphate variations
Time Frame: 2 hours
2 hours
Serum gastrin variations
Time Frame: 2 hours
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Eastern Piedmont

Collaborators

University of Milan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

January 1, 2005

Study Completion (Actual)

January 1, 2005

Study Registration Dates

First Submitted

January 4, 2010

First Submitted That Met QC Criteria

January 4, 2010

First Posted (Estimate)

January 5, 2010

Study Record Updates

Last Update Posted (Estimate)

January 5, 2010

Last Update Submitted That Met QC Criteria

January 4, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NO012010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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