Racial Differences in Phosphorus Metabolism

NCT00856726 | Completed Results

• 2 other identifiers: 20080669K23DK081673
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Control

Outcome Measures

Primary Outcomes (1)

• Urinary Phosphorus Excretion

  Fractional excretion of phosphorus (the fraction of phosphorus filtered by the kidney which is excreted in the urine)

  six hours

Secondary Outcomes (5)

• Fibroblast Growth Factor 23

  six hours

• Serum Phosphorus

  six hours

• Serum Calcium

  six hours

• Parathyroid Hormone

  six hours

• Fractional Excretion of Calcium

  six hours

Study Arms (1)

PTH infusion

EXPERIMENTAL

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

Drug: 1-34 parathyroid infusion

Interventions

1-34 parathyroid infusion DRUG

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

PTH infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Miami: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (1)

• Gutierrez 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.

  PMID: 22246283 RESULT

Limitations and Caveats

It is possible that the length of the intervention needed to be longer to detect racial differences in phosphorus excretion.

Results Point of Contact

• Title: Orlando Gutierrez
• Organization: University of Alabama at Birmingham

ogutierrez@uabmc.edu

205-996-2736

Study Officials

• Orlando M Gutierrez, MD, MMSc

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 4, 2009
• First Posted: March 6, 2009
• Study Start: February 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: September 11, 2017
• Results First Posted: September 11, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)