Study of Dietary Phosphate and Mineral Homeostasis in Early Chronic Kidney Disease

University of British Columbia

Status

Completed

Conditions

Kidney Diseases

Treatments

Behavioral: High/ Low Phosphate diet

Study type

Interventional

Funder types

Other

Identifiers

NCT00755690

H08-01018

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

32 participants in 3 patient groups

Active Comparator group

Description:

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.

Treatment:

Behavioral: High/ Low Phosphate diet

Active Comparator group

Description:

High/ Low Phosphate diet

Treatment:

Behavioral: High/ Low Phosphate diet

Active Comparator group

Description:

High/ Low Phosphate diet

Treatment:

Behavioral: High/ Low Phosphate diet