Analysis of Calcium Balance in Chronic Kidney Disease
This study has been completed.
Sponsor:
University of Colorado, Denver
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00974532
First received: June 3, 2009
Last updated: December 3, 2012
Last verified: September 2009
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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 Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Phosphorus balance [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
- PTH [ Time Frame: 2 WEEKS ] [ Designated as safety issue: No ]
- FGF-23 [ Time Frame: 2 WEEKS ] [ Designated as safety issue: No ]
| 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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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 More Information
Publications:
| Responsible Party: | University of Colorado, Denver |
| ClinicalTrials.gov Identifier: | NCT00974532 History of Changes |
| Other Study ID Numbers: | 07-0959, G195 |
| Study First Received: | June 3, 2009 |
| Last Updated: | December 3, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Colorado, Denver:
|
balance chronic kidney disease calcium phosphorus |
Additional relevant MeSH terms:
|
Kidney Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic Urologic Diseases Renal Insufficiency |
Calcium, Dietary Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013