Text Size

Racial Differences in Phosphorus Metabolism

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
University of Miami
ClinicalTrials.gov Identifier:
NCT00856726
First received: March 4, 2009
Last updated: June 30, 2011
Last verified: September 2010
History of Changes
  Purpose

The investigators aim to study potential racial differences in renal phosphorus handling by provocatively testing urinary phosphorus excretion using parathyroid hormone infusions in healthy white volunteers compared to healthy black volunteers.


Condition Intervention
Healthy Volunteers
 Drug: 1-34 parathyroid infusion

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Racial Differences in Phosphorus Metabolism

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Urinary phosphorus excretion [ Time Frame: six hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: February 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: 1-34 parathyroid infusion
    1-34 parathyroid infusion at 0.055 mcg/kg/hr for 6 hours
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Body mass index (BMI) within 20% ideal for their age and gender

Exclusion Criteria:

  • Abnormal urinalysis
  • Pregnancy or breast-feeding
  • Medical conditions impacting phosphorus metabolism—primary hyperparathyroidism; diabetes mellitus; gastrointestinal malabsorption disorders; hyper- or hypothyroidism
  • Medications known to affect phosphorus metabolism— current use of phosphorus supplements, phosphorus binders, calcitriol or calcitriol analogues, regular antacid or laxative use, calcitonin, etidronate, anticonvulsants
  • Hyper- or hypophosphatemia (≥ 4.6 mg/dl or ≤ 2.5 mg/dl respectively), hyper- or hypocalcemia (≥ 10.6 or ≤ 8.5 mg/dl respectively), or severe anemia (Hgb < 8 g/dl for women and < 9 g/dl for men)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00856726

Locations
United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
National Institutes of Health (NIH)
Investigators
Principal Investigator: Orlando M Gutierrez, MD, MMSc University of Miami
  More Information

No publications provided

Responsible Party: Orlando M. Gutierrez, MD, MMSc, University of Miami
ClinicalTrials.gov Identifier: NCT00856726     History of Changes
Other Study ID Numbers: 20080669, K23DK081673
Study First Received: March 4, 2009
Last Updated: June 30, 2011
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 19, 2013