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Analysis of Calcium Balance in Chronic Kidney Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00974532
First Posted: September 10, 2009
Last Update Posted: December 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Colorado, Denver
  Purpose
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.

Condition Intervention
Chronic Kidney Disease Dietary Supplement: High calcium diet 2000 mg/day Dietary Supplement: Low calcium diet, 800 mg/day

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Analysis of Calcium Balance in Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Calcium balance [ Time Frame: 48 hour ]

Secondary Outcome Measures:
  • Phosphorus balance [ Time Frame: 48 hours ]
  • PTH [ Time Frame: 2 WEEKS ]
  • FGF-23 [ Time Frame: 2 WEEKS ]

Enrollment: 16
Study Start Date: May 2008
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Subjects with normal kidney function
eGFR > 60 ml/min/m²
Dietary Supplement: High calcium diet 2000 mg/day
High calcium (2000 mg elemental calcium) diet x 9 days
Dietary Supplement: Low calcium diet, 800 mg/day
Low calcium (800 mg elemental calcium) diet x 9 days
Experimental: CKD late Stage 3 and Stage 4
eGFR 15-40 ml/min/m²
Dietary Supplement: High calcium diet 2000 mg/day
High calcium (2000 mg elemental calcium) diet x 9 days
Dietary Supplement: Low calcium diet, 800 mg/day
Low calcium (800 mg elemental calcium) diet x 9 days

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 1. 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00974532


Locations
United States, Colorado
University of Colorado Denver Health Sciences Center
Denver, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
  More Information

Publications:
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00974532     History of Changes
Other Study ID Numbers: 07-0959
G195
First Submitted: June 3, 2009
First Posted: September 10, 2009
Last Update Posted: December 5, 2012
Last Verified: September 2009

Keywords provided by University of Colorado, Denver:
balance
chronic kidney disease
calcium
phosphorus

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs


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