Racial Differences in Phosphorus Metabolism

Control Clinical Trial

Official title:

Racial Differences in Phosphorus Metabolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00856726
• Other study ID #: 20080669
• Secondary ID: K23DK081673
• Status: Completed
• Phase: N/A
• First received: March 4, 2009
• Last updated: September 5, 2017
• Start date: February 2009
• Est. completion date: June 2011

Study information

• Verified date: September 2017
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Control

Intervention

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

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of Miami	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Gutiérrez OM, Smith KT, Barchi-Chung A, Patel NM, Isakova T, Wolf M. (1-34) Parathyroid hormone infusion acutely lowers fibroblast growth factor 23 concentrations in adult volunteers. Clin J Am Soc Nephrol. 2012 Jan;7(1):139-45. doi: 10.2215/CJN.06240611. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary Phosphorus Excretion	Fractional excretion of phosphorus (the fraction of phosphorus filtered by the kidney which is excreted in the urine)	six hours
Secondary	Fibroblast Growth Factor 23	The change in fibroblast growth factor 23 concentrations from baseline to six hours	six hours
Secondary	Serum Phosphorus	change in serum phosphorus from baseline to six hours	six hours
Secondary	Serum Calcium	change in serum calcium from baseline to six hours	six hours
Secondary	Parathyroid Hormone	change in parathyroid hormone from baseline to six hours	six hours
Secondary	Fractional Excretion of Calcium	change in urinary fractional excretion of calcium from baseline to six hours	six hours