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OpenTrials
Completed

NCT Number: NCT00856726

Racial Differences in Phosphorus Metabolism

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.

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Key information

Conditions

Control

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

1-34 parathyroid infusion

Drug

1-34 parathyroid infusion at 0.055 mcg/kg/hr for 6 hours

Primary outcomes

  1. 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 outcomes

  1. Fibroblast Growth Factor 23

    Time frame: six hours

    The change in fibroblast growth factor 23 concentrations from baseline to six hours

  2. Serum Phosphorus

    Time frame: six hours

    change in serum phosphorus from baseline to six hours

  3. Serum Calcium

    Time frame: six hours

    change in serum calcium from baseline to six hours

  4. Parathyroid Hormone

    Time frame: six hours

    change in parathyroid hormone from baseline to six hours

  5. Fractional Excretion of Calcium

    Time frame: six hours

    change in urinary fractional excretion of calcium from baseline to six hours

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Mar 6, 2009
Registry last updated
Sep 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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