Dietary Phosphate and Serum Phosphorus

Phosphorus Metabolism Disorders Clinical Trial

Official title:

Nutrition Risk Screening in Chronic Kidney Disease (CKD) From the National Health and Nutrition Examination Survey

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02435017
• Other study ID #: Pro00001798
• Status: Completed
• Start date: January 2003
• Est. completion date: July 2009

Study information

• Verified date: September 2018
• Source: The Methodist Hospital System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Overall study design is to review National Health and Nutrition Examination Survey (NHANES) data 1999-2008 for nutrition risk according to kidney function. Substudies will be performed to review the association of nutrients and overall dietary intake compared to biomarkers available in NHANES during this period.

Description:

Data from NHANES 2003-2006 were used to evaluate the relationship between estimated dietary phosphorus intake and the measured serum phosphorus. The following variables were used:

1. Demographics: Age, sex, race/ethnicity

2. Dietary variables: Foods, food groups (as reported by the United States Department of Agriculture (USDA) method, further standardized to the Academy of Nutrition and Dietetics method for portion size and then divided into groups having inorganic phosphate additives or no inorganic phosphate additives), food weight (g), phosphorus (mg), dietary supplements

3. Socioeconomic variables: education, family income

4. Laboratory variables: serum creatinine, phosphorus; urine albumin, creatinine

5. Clinical assessments: hypertension (proportion having blood pressure ≥140 millimeters of mercury (mmHg) diastolic or ≥90 mmHg systolic or taking antihypertensive medications); hyperglycemia (proportion having serum glucose >126 mg/dL or taking medications for diabetes); kidney function based on Chronic Kidney Disease Epidemiology Collaboration (2009) equation, evaluated in 15 milliliters/min/1.73m2 increments from <15 to >105; anthropometrics (BMI, kg/m2; obesity class I, II, III)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7895
• Est. completion date: July 2009
• Est. primary completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

• Serum creatinine

Exclusion Criteria:

• Pregnancy

• No dietary intake interview

• Dietary intake interview not valid

• Answered the question "Have you had dialysis in the past year?" as "Yes"

Related Conditions & MeSH terms

• Metabolic Diseases
• Phosphorus Metabolism Disorders

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Linda W. Moore	The Methodist Hospital System

References & Publications (1)

Moore LW, Byham-Gray LD, Scott Parrott J, Rigassio-Radler D, Mandayam S, Jones SL, Mitch WE, Osama Gaber A. The mean dietary protein intake at different stages of chronic kidney disease is higher than current guidelines. Kidney Int. 2013 Apr;83(4):724-32. doi: 10.1038/ki.2012.420. Epub 2013 Jan 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum phosphorus concentration	Serum phosphorus concentration on the day that 24-hour dietary recall was obtained (reflecting dietary intake the day prior to blood draw); measured in mg/dL	approximately 24 hours
Secondary	Kidney function level	Kidney function estimated from Chronic Kidney Disease Epidemiology Collaboration (2009) equation, mL/min/1.73m2, and separated into 15mL/min increments	Baseline