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This study is designed to describe the physiological response to increased and decreased dietary phosphate intake on various parameters of mineral metabolism in the blood and urine of individuals with Chronic Kidney Disease stage 3 and 4 with normal serum phosphate levels. This detailed study will give us a far greater understanding of the role of diet in abnormal mineral homeostasis early in the progression of this chronic disease. The findings of this study will help both physicians and dietitians better determine the optimal time to introduce dietary therapy in CKD.
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 ;
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | 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. |
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| 2 | Active Comparator | High/ Low Phosphate diet |
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| 3 | Active Comparator | High/ Low Phosphate diet |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High/ Low Phosphate diet | Behavioral | Low phosphate diet (750mg/day). |
| |
| Measure | Description | Time Frame |
|---|---|---|
| FGF-23 | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Serum calcium, phosphate, PTH, 25 and 1,25 vitamin D and fractional phosphate excretion. | 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adeera Levin, MD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Paul's Hospital | Vancouver | British Columbia | Canada |
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| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| High/ Low Phosphate diet |
| Behavioral |
Low phosphate diet (750mg/day) with the addition of the phosphate binder aluminum hydroxide (500mg three times per day). |
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| High/ Low Phosphate diet | Behavioral | III. High phosphate diet (2000mg /day). |
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| D052801 | Male Urogenital Diseases |
| D051437 | Renal Insufficiency |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |