Study of Dietary Phosphate and Mineral Homeostasis in Early Chronic Kidney Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The potential benefits of implementation of phosphate management earlier in CKD (Stages 3/4) are threefold: 1) prevention of vascular damage early in the progression of CKD thus reducing risk of cardiovascular death 2) Improved management of renal bone disease and resultant co-morbidities and 3) slowing the progression of renal failure lengthening the time required till dialysis is required. Although dietary counseling is currently a normal part of CKD care, the utility and effectiveness of lowering phosphate has not previously been quantified. In part this is due to the difficulty of measurement of serum phosphate as it is so tightly controlled before GFR falls below 30mls/min. No studies have investigated whether is it possible to modulate circulating FGF-23 and phosphate excretion in early stages of renal failure using diet in individuals with normal serum phosphate levels.
Study Objectives ;
- To measure FGF-23 levels before and after a high phosphate diet, low phosphate diet and a low phosphate diet with phosphate binders.
- To measure levels of calcium, phosphate, PTH, 25 and 1,25 vitamin D and fractional phosphate excretion before and after a high phosphate diet, low phosphate diet and a low phosphate diet with phosphate binders.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
British Columbia
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Vancouver, British Columbia, Canada
- St. Paul's Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- CKD patients with CKD stage 3 and 4 (eGFR < 60 ml/min and > 15 ml/min per 1.73 m2, not requiring dialysis).
- Normal serum phosphate stable over three months (> 0.87 mmol/L and < 1.70 mmol/L)
- Not yet following a low phosphate diet as reported by the patient or the renal dietitian (<1500mg/d)
- Over 19 years of age
Exclusion Criteria:
- Body mass index <20 kg/m2
- Current use of phosphate binders or active vitamin D or phenytonin (which induces vitamin D catabolism)
- Primary parathyroid defects
- Diagnosed osteoporosis
- Gut absorption defects
- Liver disease
- Pregnancy or lactation
- Patients hospitalised within the last 4 weeks
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1
High/ Low Phosphate diet I. A five-day low phosphate diet / A five-day low phosphate diet with the addition of a phosphate binder / A five-day high phosphate diet. II. A five-day low phosphate diet / A five-day high phosphate diet / A five-day low phosphate diet with the addition of a phosphate binder III. A five-day high phosphate diet / A five-day low phosphate diet with the addition of a phosphate binder / A five-day low phosphate diet. IV. A five-day high phosphate diet / A five-day low phosphate diet / A five-day low phosphate diet with the addition of a phosphate binder. V. A five-day low phosphate diet with the addition of a phosphate binder / A five-day low phosphate diet / A five-day high phosphate diet. VI. A five-day low phosphate diet with the addition of a phosphate binder / A five-day high phosphate diet / A five-day low phosphate diet. |
Low phosphate diet (750mg/day).
Low phosphate diet (750mg/day) with the addition of the phosphate binder aluminum hydroxide (500mg three times per day).
III. High phosphate diet (2000mg /day).
|
|
Active Comparator: 2
High/ Low Phosphate diet
|
Low phosphate diet (750mg/day).
Low phosphate diet (750mg/day) with the addition of the phosphate binder aluminum hydroxide (500mg three times per day).
III. High phosphate diet (2000mg /day).
|
|
Active Comparator: 3
High/ Low Phosphate diet
|
Low phosphate diet (750mg/day).
Low phosphate diet (750mg/day) with the addition of the phosphate binder aluminum hydroxide (500mg three times per day).
III. High phosphate diet (2000mg /day).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
FGF-23
Time Frame: 5 days
|
5 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Serum calcium, phosphate, PTH, 25 and 1,25 vitamin D and fractional phosphate excretion.
Time Frame: 5 days
|
5 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Adeera Levin, MD, University of British Columbia
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H08-01018
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