Racial Differences in Phosphorus Metabolism

NCT ID: NCT00856726

Last Updated: 2017-09-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-06-30

Brief Summary

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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

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Conditions

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Control

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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PTH infusion

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

Group Type EXPERIMENTAL

1-34 parathyroid infusion

Intervention Type DRUG

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

Interventions

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1-34 parathyroid infusion

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

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Orlando M. Gutierrez, MD, MMSc

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Orlando M Gutierrez, MD, MMSc

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami

Miami, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 22246283 (View on PubMed)

Other Identifiers

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K23DK081673

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20080669

Identifier Type: -

Identifier Source: org_study_id

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