NCT00974532

Brief Summary

Subjects with normal kidney function are able to excrete in their urine the calcium and phosphorus absorbed via the gastrointestinal tract and are thereby are able to maintain calcium and phosphorus balance. Patients with chronic kidney disease often have normal blood levels of calcium and phosphorus but no research has been conducted to determine if they are able to excrete their daily intake of these minerals. If they are not able to excrete their daily intake, these minerals could be deposited in soft tissue and blood vessels and contribute to the increased risk of cardiovascular disease seen in patients with chronic kidney disease. This study will determine if subjects with chronic kidney disease are in balance primarily with regard to calcium and at what level of kidney function they are no longer able to maintain balance. Understanding whether patients with chronic kidney disease are in balance will help direct future therapeutic interventions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2008

Longer than P75 for not_applicable

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

May 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2009

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 10, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

December 5, 2012

Status Verified

September 1, 2009

Enrollment Period

3.8 years

First QC Date

June 3, 2009

Last Update Submit

December 3, 2012

Conditions

Chronic Kidney Disease

Keywords

balancechronic kidney diseasecalciumphosphorus

Outcome Measures

Primary Outcomes (1)

  • Calcium balance

    48 hour

Secondary Outcomes (3)

  • Phosphorus balance

    48 hours

  • PTH

    2 WEEKS

  • FGF-23

    2 WEEKS

Study Arms (2)

Subjects with normal kidney function

ACTIVE COMPARATOR

eGFR \> 60 ml/min/m²

Dietary Supplement: High calcium diet 2000 mg/dayDietary Supplement: Low calcium diet, 800 mg/day

CKD late Stage 3 and Stage 4

EXPERIMENTAL

eGFR 15-40 ml/min/m²

Dietary Supplement: High calcium diet 2000 mg/dayDietary Supplement: Low calcium diet, 800 mg/day

Interventions

High calcium diet 2000 mg/dayDIETARY_SUPPLEMENT

High calcium (2000 mg elemental calcium) diet x 9 days

CKD late Stage 3 and Stage 4Subjects with normal kidney function
Low calcium diet, 800 mg/dayDIETARY_SUPPLEMENT

Low calcium (800 mg elemental calcium) diet x 9 days

CKD late Stage 3 and Stage 4Subjects with normal kidney function

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women 18 years of age or greater and able to comply with the study protocol.
  • eGFR within appropriate target ranges (15-40 ml/min/m² for late stage CKD stage 3 stage 4, and eGFR \> 60 ml/min/m² for normal subjects)
  • Stable kidney function defined as an eGFR which remains within a 10ml/min range over a 3 to 6 month period prior to study enrollment. This will be determined from historical laboratory data.
  • Willing to follow study protocol
  • Have a level of understanding and willingness to cooperate with all visits and procedures as described by the study personnel
  • Overall stable medical condition, defined as no malignancy, metabolic condition or gastrointestinal condition that would make it difficult to comply with the study protocol and complete both dietary study periods
  • Able to read the consent form and provide informed consent.
  • Serum calcium and phosphorus within the normal range off of vitamin D analogues, calcium supplements, and phosphate binders for 1 month.

You may not qualify if:

  • \. Age less than 18 years
  • Are pregnant, plan on becoming pregnant during the study period, or breast-feeding, if female.
  • Patient declines participation.
  • GI malabsorption, short bowel syndrome, frequent vomiting, or gastroparesis.
  • Subject receiving synthetic parathyroid hormone, glucocorticoids, calcitonin or bisphosphonates.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Denver Health Sciences Center

Denver, Colorado, 80045, United States

Location

Related Publications (1)

  • Spiegel DM, Brady K. Calcium balance in normal individuals and in patients with chronic kidney disease on low- and high-calcium diets. Kidney Int. 2012 Jun;81(11):1116-22. doi: 10.1038/ki.2011.490. Epub 2012 Feb 1.

    PMID: 22297674RESULT

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

First Submitted

June 3, 2009

First Posted

September 10, 2009

Study Start

May 1, 2008

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

December 5, 2012

Record last verified: 2009-09

Locations

US(1)