Circadian Rhythm Modulation by Dietary Phosphorus in Chronic Kidney Disease

NCT01341678 | Completed

• 1 other identifier: CMD 004
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Disease

Keywords

chronic kidney disease; phosphorus; circadian rhythm; saliva

Outcome Measures

Primary Outcomes (3)

• Circadian rhythm of serum phosphorus

  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.

  24 hour

• Circadian rhythm of plasma fibroblast growth factor 23 (FGF23)

  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.

  24 hours

• Circadian rhythm of salivary phosphorus

  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.

  24 hours

Study Arms (3)

Normal Phosphorus Diet

OTHER

Diet containing 1500mg of phosphorus per day

Other: Diet Only

Restricted Phosphorus Diet

OTHER

Diet containing 750mg of phosphorus per day and administration of a phosphate binder (lanthanum carbonate)

Drug: Lanthanum Carbonate

High Phosphorus Diet

OTHER

Diet containing 3000mg of phosphorus per day and phosphorus supplementation (NeutraPhos)

Dietary Supplement: NeutraPhos

Interventions

Lanthanum Carbonate DRUG

Diet will be supplemented with 1000mg at each meal

Also known as: Fosrenol

Restricted Phosphorus Diet

NeutraPhos DIETARY_SUPPLEMENT

Diet will be supplemented with NeutraPhos

Also known as: Phosphorus supplementation

High Phosphorus Diet

Diet Only OTHER

Diet containing 1500mg of phosphorus

Normal Phosphorus Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Geoffrey Block: lead

Study Sites (1)

Denver Nephrologists, PC

Denver, Colorado, 80230, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

lanthanum carbonate

Condition Hierarchy (Ancestors)

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

Study Officials

• Geoffrey A Block, MD

  Denver Nephrologists, PC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Research

Study Record Dates

• First Submitted: April 23, 2011
• First Posted: April 26, 2011
• Study Start: April 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: February 11, 2014

Record last verified: 2011-04

Locations

US (1)