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

NCT00755690 | Completed

• 1 other identifier: H08-01018
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Diseases

Keywords

Chronic Kidney Disease; CKD; Diet; Dietary Phosphate; Mineral Metabolism; FGF-23

Outcome Measures

Primary Outcomes (1)

• FGF-23

  5 days

Secondary Outcomes (1)

• Serum calcium, phosphate, PTH, 25 and 1,25 vitamin D and fractional phosphate excretion.

  5 days

Study Arms (3)

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.

Behavioral: High/ Low Phosphate diet

2

ACTIVE COMPARATOR

High/ Low Phosphate diet

Behavioral: High/ Low Phosphate diet

3

ACTIVE COMPARATOR

High/ Low Phosphate diet

Behavioral: High/ Low Phosphate diet

Interventions

High/ Low Phosphate diet BEHAVIORAL

Low phosphate diet (750mg/day).

1

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Kidney Diseases; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Adeera Levin, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2008
• First Posted: September 19, 2008
• Study Start: September 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: February 19, 2014

Record last verified: 2014-02

Locations

CA (1)