NCT00187629

Brief Summary

The purpose of this study is to determine the effects of different amounts of phosphorus in the diet on hormones that control phosphorus and bone health both in men who are healthy and in ones who have moderate kidney disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Mar 2004

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

October 9, 2013

Status Verified

October 1, 2013

Enrollment Period

4.3 years

First QC Date

September 13, 2005

Last Update Submit

October 8, 2013

Conditions

HealthyKidney Failure, Chronic

Outcome Measures

Primary Outcomes (1)

  • urine phosphorus

    Daily

Study Arms (2)

1

EXPERIMENTAL

dietary phosphorus

Behavioral: dietary phosphorus

2

ACTIVE COMPARATOR

other

Behavioral: dietary phosphorus

Interventions

dietary phosphorusBEHAVIORAL

varying amts dietary phosphorus

12

Eligibility Criteria

Age21 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy Men 21-65 years old with Creatinine clearance \> 70 ml/min/1.73 m2 as calculated using the equation derived from the Modification of Diet in Renal Disease (MDRD) study
  • Men 21-65 years old with Creatinine clearance between 30 and 59 ml/min/1.73 m2 as calculated using the equation derived from the MDRD study31

You may not qualify if:

  • Medications affecting bone metabolism
  • Abnormal liver or GI function
  • Extreme electrolyte abnormalities
  • BMI \>30 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Phosphorus, Dietary

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phosphorus CompoundsInorganic Chemicals

Study Officials

  • Diana M Antoniucci, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

March 1, 2004

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

October 9, 2013

Record last verified: 2013-10

Locations

US(1)