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Racial Differences in Phosphorus Metabolism

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Orlando M. Gutierrez, MD, MMSc, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00856726
First received: March 4, 2009
Last updated: September 5, 2017
Last verified: September 2017
  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
Control Drug: 1-34 parathyroid infusion

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Racial Differences in Phosphorus Metabolism

Resource links provided by NLM:


Further study details as provided by Orlando M. Gutierrez, MD, MMSc, University of Alabama at Birmingham:

Primary Outcome Measures:
  • Urinary Phosphorus Excretion [ Time Frame: six hours ]
    Fractional excretion of phosphorus (the fraction of phosphorus filtered by the kidney which is excreted in the urine)


Secondary Outcome Measures:
  • Fibroblast Growth Factor 23 [ Time Frame: six hours ]
    The change in fibroblast growth factor 23 concentrations from baseline to six hours

  • Serum Phosphorus [ Time Frame: six hours ]
    change in serum phosphorus from baseline to six hours

  • Serum Calcium [ Time Frame: six hours ]
    change in serum calcium from baseline to six hours

  • Parathyroid Hormone [ Time Frame: six hours ]
    change in parathyroid hormone from baseline to six hours

  • Fractional Excretion of Calcium [ Time Frame: six hours ]
    change in urinary fractional excretion of calcium from baseline to six hours


Enrollment: 26
Study Start Date: February 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PTH infusion
(1-34) PTH infusion at a rate of 0.055 ug/kg/hour for six hours
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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Orlando M Gutierrez, MD, MMSc University of Miami
  More Information

Publications:
Responsible Party: Orlando M. Gutierrez, MD, MMSc, Associate Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00856726     History of Changes
Other Study ID Numbers: 20080669
K23DK081673 ( U.S. NIH Grant/Contract )
Study First Received: March 4, 2009
Results First Received: June 5, 2017
Last Updated: September 5, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

ClinicalTrials.gov processed this record on September 21, 2017