Racial Differences in Phosphorus Metabolism

Not Applicable

Completed

• Conditions: Control
• Interventions: Drug: 1-34 parathyroid infusion

• Registration Number: NCT00856726
• Lead Sponsor: University of Miami

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-03-04
• Study First Submitted QC: 2009-03-05
• Study First Posted: 2009-03-06
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Results First Submitted: 2017-06-05
• Status Verified: 2017-09
• Results First Submitted QC: 2017-09-05
• Last Update Submitted: 2017-09-05
• Results First Posted: 2017-09-11
• Last Update Posted: 2017-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PTH infusion	1-34 parathyroid infusion	(1-34) PTH infusion at a rate of 0.055 ug/kg/hour for six hours

Primary Outcome Measures

Name	Time	Method
Urinary Phosphorus Excretion	six hours	Fractional excretion of phosphorus (the fraction of phosphorus filtered by the kidney which is excreted in the urine)

Secondary Outcome Measures

Name	Time	Method
Fibroblast Growth Factor 23	six hours	The change in fibroblast growth factor 23 concentrations from baseline to six hours
Serum Phosphorus	six hours	change in serum phosphorus from baseline to six hours
Serum Calcium	six hours	change in serum calcium from baseline to six hours
Parathyroid Hormone	six hours	change in parathyroid hormone from baseline to six hours
Fractional Excretion of Calcium	six hours	change in urinary fractional excretion of calcium from baseline to six hours

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States