Analysis of Calcium Balance in Chronic Kidney Disease

Completed · Not applicable

Conditions studied: Chronic Kidney Disease

In brief

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.

Key facts

Study ID

NCT00974532

Run by

University of Colorado, Denver

People needed

16

Starts

2008-05-01

Expected to finish

2012-02-01

Last updated by the study team

2012-12-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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…

• 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.

Where it is running

• University of Colorado Denver Health Sciences Center — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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