Circadian Rhythm Modulation by Dietary Phosphorus in Chronic Kidney Disease
This study has been completed.
Sponsor:
Denver Nephrologists, P.C.
Collaborator:
CM&D Pharma, LTD
Information provided by:
Denver Nephrologists, P.C.
ClinicalTrials.gov Identifier:
NCT01341678
First received: April 23, 2011
Last updated: November 11, 2011
Last verified: April 2011
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Purpose
The purpose of this study is to describe the circadian rhythm of serum and salivary phosphorus in patients with chronic kidney disease and determine its' modification in response to changes in dietary phosphate load.
| Condition | Intervention |
|---|---|
|
Chronic Kidney Disease |
Drug: Lanthanum Carbonate Dietary Supplement: NeutraPhos Other: Diet Only |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | Circadian Rhythm Modulation by Dietary Phosphorus in Chronic Kidney Disease (CKD) |
Resource links provided by NLM:
Further study details as provided by Denver Nephrologists, P.C.:
Primary Outcome Measures:
- Circadian rhythm of serum phosphorus [ Time Frame: 24 hour ] [ Designated as safety issue: No ]After 1 week of a controlled phosphorus diet patients will be hospitalized for 24 hours and serum phosphorus will be obtained every 4 hours. After a 4 day washout, each subject will cross over to a low phosphorus diet (for 1 week) followed by a 4 day washout and cross over to a high phosphorus diet for 1 week. At the end of each weekly diet a 24 hour hospitalization will occur with samples collected every 4 hours.
- Circadian rhythm of plasma fibroblast growth factor 23 (FGF23) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]After 1 week of a controlled phosphorus diet patients will be hospitalized for 24 hours and FGF23 will be obtained every 4 hours. After a 4 day washout, each subject will cross over to a low phosphorus diet (for 1 week) followed by a 4 day washout and cross over to a high phosphorus diet for 1 week. At the end of each weekly diet a 24 hour hospitalization will occur with samples collected every 4 hours.
- Circadian rhythm of salivary phosphorus [ Time Frame: 24 hours ] [ Designated as safety issue: No ]After 1 week of a controlled phosphorus diet patients will be hospitalized for 24 hours and salivary phosphorus will be obtained every 4 hours. After a 4 day washout, each subject will cross over to a low phosphorus diet (for 1 week) followed by a 4 day washout and cross over to a high phosphorus diet for 1 week. At the end of each weekly diet a 24 hour hospitalization will occur with samples collected every 4 hours.
| Estimated Enrollment: | 12 |
| Study Start Date: | April 2011 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Normal Phosphorus Diet
Diet containing 1500mg of phosphorus per day
|
Other: Diet Only
Diet containing 1500mg of phosphorus
|
|
Restricted Phosphorus Diet
Diet containing 750mg of phosphorus per day and administration of a phosphate binder (lanthanum carbonate)
|
Drug: Lanthanum Carbonate
Diet will be supplemented with 1000mg at each meal
Other Name: Fosrenol
|
|
High Phosphorus Diet
Diet containing 3000mg of phosphorus per day and phosphorus supplementation (NeutraPhos)
|
Dietary Supplement: NeutraPhos
Diet will be supplemented with NeutraPhos
Other Name: Phosphorus supplementation
|
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 or women greater than or equal to 18 years of age
- The subject has voluntarily signed and dated the most recent informed consent form approved by an Institutional Review Board
- Screening estimated glomerular filtration rate (eGRF) greater than or equal to 30 and less than or equal to 45 mL/min/1.72m2 plus or minus 10% for subjects with CKD and greater than 60mL/min for subjects acting as normal healthy controls
- Willing and able to cooperate with all aspects of the study protocol
- No evidence of significant gastrointestinal (GI) disorder that would impair GI motility or function
- No recent active illness or hospitalization within 12 weeks prior to the Day 1/Baseline visit
- No recent or voluntary change in diet within 4 weeks prior to Day 1/ Baseline visit
- No history of intolerance or adverse effects to lanthanum carbonate
- No use of calcium supplements for at least 2 weeks prior to Day 1
- Must have no dietary restrictions or significant allergies and be willing to eat a non-vegan standardized meal
- Subjects taking nutritional vitamin D or any active vitamin D must be on stable doses with no change during the 4 week period prior to Day 1
Exclusion Criteria:
- Current history of drug or alcohol abuse as assessed by the Principal Investigator
- Receiving active chemotherapy treatment for a malignancy
- Has received dialysis or has acute kidney injury within 12 weeks prior to screening or during screening
- Subject has a clinical condition that in the judgement of the Principal Investigator could potentially pose a health risk to the patient while involved int he study
- Received or has received an investigational product (or is currently using an investigational device) within 30 days prior to screening
- Evidence of active (clinically significant) infections within 14 days prior to Day1/ Baseline visit (in the opinion of the investigator)
- Use of phosphate binding medications (calcium carbonate or acetate with meals, lanthanum carbonate, or sevelamer carbonate)within 7 days prior to the Day 1/ Baseline visit
- Significant GI co-morbidity that would preclude use of lanthanum carbonate phosphate binder (e.g. colostomy with unformed stool, uncontrolled diarrhea)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01341678
Locations
| United States, Colorado | |
| Denver Nephrologists, PC | |
| Denver, Colorado, United States, 80230 | |
Sponsors and Collaborators
Denver Nephrologists, P.C.
CM&D Pharma, LTD
Investigators
| Principal Investigator: | Geoffrey A Block, MD | Denver Nephrologists, PC |
More Information
No publications provided
| Responsible Party: | Geoffrey A. Block, MD, Denver Nephrology |
| ClinicalTrials.gov Identifier: | NCT01341678 History of Changes |
| Other Study ID Numbers: | CMD 004 |
| Study First Received: | April 23, 2011 |
| Last Updated: | November 11, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Denver Nephrologists, P.C.:
|
chronic kidney disease phosphorus circadian rhythm saliva |
Additional relevant MeSH terms:
|
Kidney Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic Urologic Diseases Renal Insufficiency |
ClinicalTrials.gov processed this record on May 16, 2013