Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dietary Phosphate and Serum Phosphorus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02435017
Recruitment Status : Completed
First Posted : May 6, 2015
Last Update Posted : September 17, 2018
Sponsor:
Collaborator:
The Methodist Hospital System
Information provided by (Responsible Party):
Linda W. Moore, The Methodist Hospital System

Brief 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.

Condition or disease
Phosphorus Metabolism Disorders

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)

Layout table for study information
Study Type : Observational
Actual Enrollment : 7895 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Nutrition Risk Screening in Chronic Kidney Disease (CKD) From the National Health and Nutrition Examination Survey
Study Start Date : January 2003
Actual Primary Completion Date : December 2006
Actual Study Completion Date : July 2009

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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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"

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02435017


Sponsors and Collaborators
Linda W. Moore
The Methodist Hospital System
Investigators
Layout table for investigator information
Principal Investigator: Linda W Moore, MS Director, Clinical Trials; Dept of Surgery
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Linda W. Moore, Sponsor-Investigator/Principal Investigator, The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT02435017    
Other Study ID Numbers: Pro00001798
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Plan to share data to be determined.
Keywords provided by Linda W. Moore, The Methodist Hospital System:
kidney disease
recommended dietary allowances
nutrition assessment
food
dietary proteins
Vitamin D
dietary fats
ethnology
Continental Population Groups
Phosphorus, dietary
Phosphorus/analysis
Additional relevant MeSH terms:
Layout table for MeSH terms
Metabolic Diseases
Phosphorus Metabolism Disorders