NCT00305279

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 people who are healthy and in ones who have moderate kidney disease.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2006

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
withdrawn

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

February 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 17, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 21, 2006

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

October 10, 2013

Status Verified

October 1, 2013

Enrollment Period

3.8 years

First QC Date

March 17, 2006

Last Update Submit

October 9, 2013

Conditions

HealthyKidney Failure, Chronic

Outcome Measures

Primary Outcomes (1)

  • Hormonal regulators of mineral metabolism

    Last two days of each intervention phase

Study Arms (3)

1

ACTIVE COMPARATOR
Other: Dietary

2

ACTIVE COMPARATOR
Other: Dietary

3

ACTIVE COMPARATOR
Other: Dietary

Interventions

DietaryOTHER

Dietary

1

Eligibility Criteria

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

You may qualify if:

  • HEALTHY SUBJECTS:
  • Men 21-65 years of age;
  • Premenopausal women over 21 years of age taking oral contraceptives;
  • Postmenopausal women less than 65 years of age;
  • CHRONIC KIDNEY DISEASE SUBJECTS:
  • Men 21-65 years of age;
  • Premenopausal women over 21 years of age taking oral contraceptives;
  • Postmenopausal women less than 65 years of age;
  • Creatinine clearance between 30 and 59 ml/min/1.73 m2 as calculated using the equation derived from the Modification of Diet in Renal Disease (MDRD) study.

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

Diet

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)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Diana M Antoniucci, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2006

First Posted

March 21, 2006

Study Start

February 1, 2006

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

October 10, 2013

Record last verified: 2013-10

Locations

US(1)