ControlNCT00856726

Racial Differences in Phosphorus Metabolism

A study testing 1-34 parathyroid infusion in people with Control, run by University of Miami at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Control
What is being tested?: 1-34 parathyroid infusion
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteUnited States
Study dates: Feb 2009to Jun 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Miami
Miami, Florida, 33136

Other trials in United States

About this study

Conditions: Control
Being tested: 1-34 parathyroid infusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00856726
Study group	Role	What they receive
PTH infusion	Experimental	(1-34) PTH infusion at a rate of 0.055 ug/kg/hour for six hours Receives: Drug: 1-34 parathyroid infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (5)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2009Jun 2011

First posted6 Mar 2009 (estimated)
Study startFeb 2009
Primary completionJun 2011
Study completionJun 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for ControlStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00856726
Sponsor's protocol ID: 20080669
Other IDs: K23DK081673
Status last verified: Sep 2017
First submitted: 4 Mar 2009
Last updated: 11 Sep 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 22246283

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Racial Differences in Phosphorus Metabolism
ClinicalTrials.gov ID: NCT00856726
Acronym / sponsor ID: 20080669
Conditions: Control
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: University of MiamiUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: Feb 2009
Primary completion: Jun 2011 (actual)
Study completion: Jun 2011 (actual)
First posted: 6 Mar 2009 (estimated)
Results: Posted 11 Sep 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
PTH infusion	Experimental	Drug: 1-34 parathyroid infusion(1-34) PTH infusion at a rate of 0.055 ug/kg/hour for six hours

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (5 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
1-34 parathyroid infusion1-34 parathyroid infusion at 0.055 mcg/kg/hr for 6 hours	Drug	PTH infusion

Primary outcome

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)

5 secondary outcomes

Fibroblast Growth Factor 23
Time frame: six hours
Serum Phosphorus
Time frame: six hours
Serum Calcium
Time frame: six hours
Parathyroid Hormone
Time frame: six hours
Fractional Excretion of Calcium
Time frame: six hours

Results and safety

Results posted to the registry on 11 Sep 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PTH Infusion	26	26

Primary outcome: Urinary Phosphorus Excretion

Time frame: six hours. Mean (Standard Deviation). Unit: percentage of fractional excretion

Measure	PTH Infusion n = 26
Value	11 (0.5)

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PTH Infusion	0 of 26 (0%)	0 of 26 (0%)	Not reported

Limitations and caveats (from the sponsor): It is possible that the length of the intervention needed to be longer to detect racial differences in phosphorus excretion.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22246283Gutierrez 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.
Individual participant dataSharing planned: No

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Inflammatory Bowel Diseases (IBD), Crohn Disease
Not yet recruitingPhase 2
A Phase II Clinical Study Evaluating the Efficacy and Safety of SXRN Injection in Patients With Cancer Cachexia
Cachexia-Anorexia Syndrome, Cachexia; Cancer
Not yet recruitingPhase 3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Orlando M Gutierrez, MD, MMSc principal investigator

University of Miami

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing 1-34 parathyroid infusion in people with Control, run by University of Miami at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Urinary Phosphorus Excretion (time frame: six hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00856726, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2017.