Dietary Phosphate and Serum Phosphorus | NCT02435017

Studies
Dietary Phosphate and Serum Phosphorus

NCT02435017

Sponsor

Linda W. Moore

Status

Completed

Last Update Posted

Sep 17, 2018Actual

Enrollment

7,895Actual

Phase

Not provided

Conditions

Phosphorus Metabolism Disorders

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2003

Primary Completion Date

Dec 2006Actual

Completion Date

Jul 2009Actual

First Submitted Date

Apr 22, 2015

First Submission Date that Met QC Criteria

Apr 30, 2015

First Posted Date

May 6, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2018

Last Update Posted Date

Sep 17, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Linda W. Moore, Sponsor-Investigator/Principal Investigator, The Methodist Hospital Research InstituteSponsor-Investigator

Lead Sponsor

Linda W. MooreOTHER

Collaborators

Name	Class
The Methodist Hospital Research Institute	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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:

Demographics: Age, sex, race/ethnicity
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
Socioeconomic variables: education, family income
Laboratory variables: serum creatinine, phosphorus; urine albumin, creatinine
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)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

7,895Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adults 20-85 years		Data from adults 20-85 years old will be evaluated for serum phosphorus concentration.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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"

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Linda W Moore, MS	Director, Clinical Trials; Dept of Surgery	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23302719	Background	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.
26040641	Derived

ID	Term
D010760	Phosphorus Metabolism Disorders
D007674	Kidney Diseases

ID	Term
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases