Dietary Phosphate and Serum Phosphorus

September 13, 2018 updated by: Linda W. Moore

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

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.

Study Overview

Status

Completed

Conditions

Detailed 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)

Study Type

Observational

Enrollment (Actual)

7895

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants in the continuous NHANES program from 2003-2006 who met the inclusion/exclusion criteria were included in the analysis. NHANES samples the general US population to determine prevalence of major diseases and health risks by combining physical examination with laboratory studies and questionnaires in a standardized environment using trained personnel. Participants are selected through a complex, multistage, probability sampling approach.

Description

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"

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Adults 20-85 years
Data from adults 20-85 years old will be evaluated for serum phosphorus concentration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum phosphorus concentration
Time Frame: approximately 24 hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kidney function level
Time Frame: Baseline
Kidney function estimated from Chronic Kidney Disease Epidemiology Collaboration (2009) equation, mL/min/1.73m2, and separated into 15mL/min increments
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Linda W. Moore

Collaborators

The Methodist Hospital Research Institute

Investigators

  • Principal Investigator: Linda W Moore, MS, Director, Clinical Trials; Dept of Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

April 22, 2015

First Submitted That Met QC Criteria

April 30, 2015

First Posted (Estimate)

May 6, 2015

Study Record Updates

Last Update Posted (Actual)

September 17, 2018

Last Update Submitted That Met QC Criteria

September 13, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00001798

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Plan to share data to be determined.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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