NCT02435017

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,895

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2003

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

April 22, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 6, 2015

Completed
Last Updated

September 17, 2018

Status Verified

September 1, 2018

Enrollment Period

3.9 years

First QC Date

April 22, 2015

Last Update Submit

September 13, 2018

Conditions

Keywords

kidney diseaserecommended dietary allowancesnutrition assessmentfooddietary proteinsVitamin Ddietary fatsethnologyContinental Population GroupsPhosphorus, dietaryPhosphorus/analysis

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Kidney function level

    Baseline

Study Arms (1)

Adults 20-85 years

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

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Serum creatinine

You may not qualify if:

  • Pregnancy
  • No dietary intake interview
  • Dietary intake interview not valid
  • Answered the question "Have you had dialysis in the past year?" as "Yes"

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 23302719BACKGROUND
  • Moore LW, Nolte JV, Gaber AO, Suki WN. Association of dietary phosphate and serum phosphorus concentration by levels of kidney function. Am J Clin Nutr. 2015 Aug;102(2):444-53. doi: 10.3945/ajcn.114.102715. Epub 2015 Jun 3.

MeSH Terms

Conditions

Phosphorus Metabolism DisordersKidney Diseases

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Linda W Moore, MS

    Director, Clinical Trials; Dept of Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor-Investigator/Principal Investigator

Study Record Dates

First Submitted

April 22, 2015

First Posted

May 6, 2015

Study Start

January 1, 2003

Primary Completion

December 1, 2006

Study Completion

July 1, 2009

Last Updated

September 17, 2018

Record last verified: 2018-09