Phosphorus Metabolism DisordersNCT02435017
Dietary Phosphate and Serum Phosphorus
An observational study of Phosphorus Metabolism Disorders, run by Linda W. Moore.
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. Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Phosphorus Metabolism Disorders
- How many people
- 7,895 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Jul 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older 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.
Who may be able to join
- Serum creatinine
Who cannot join
- Pregnancy
- No dietary intake interview
- Dietary intake interview not valid
- Answered the question "Have you had dialysis in the past year?" as "Yes"
About this study
Official title: 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.
Read the 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)
- Conditions
- Phosphorus Metabolism Disorders
- Keywords
- kidney disease, recommended dietary allowances, nutrition assessment, food, dietary proteins, Vitamin D, dietary fats, ethnology, Continental Population Groups, Phosphorus, dietary, Phosphorus/analysis
- Medical subject headings
- Phosphorus Metabolism Disorders, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults 20-85 years | Data from adults 20-85 years old will be evaluated for serum phosphorus concentration. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: approximately 24 hours
Secondary outcomes (1)
Kidney function level
Kidney function estimated from Chronic Kidney Disease Epidemiology Collaboration (2009) equation, mL/min/1.73m2, and separated into 15mL/min increments
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startJan 2003
- Primary completionDec 2006
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Phosphorus Metabolism DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 7,895 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linda W. Moore
- Sponsor type
- University, hospital or other
- Collaborators
- The Methodist Hospital Research Institute
- Responsible party
- Sponsor-investigator, Linda W. Moore, The Methodist Hospital Research Institute
- Investigators
- Linda W Moore, MS, Principal investigator, Director, Clinical Trials; Dept of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435017
- Sponsor's protocol ID
- Pro00001798
- Status last verified
- Sep 2018
- First submitted
- 22 Apr 2015
- Last updated
- 17 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Plan to share data to be determined.
Publications
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.
PubMed 23302719Moore 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.
PubMed 26040641
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition Risk Screening in Chronic Kidney Disease (CKD) From the National Health and Nutrition Examination Survey
- ClinicalTrials.gov ID
- NCT02435017
- Acronym / sponsor ID
- Pro00001798
- Conditions
- Phosphorus Metabolism Disorders
- Keywords
- kidney disease, recommended dietary allowances, nutrition assessment, food, dietary proteins, Vitamin D, dietary fats, ethnology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,895 participants (actual)
- Lead sponsor
- Linda W. MooreUniversity, hospital or other
- Collaborators
- The Methodist Hospital Research Institute
- Study start
- Jan 2003
- Primary completion
- Dec 2006 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 6 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults 20-85 years | – | –Data from adults 20-85 years old will be evaluated for serum phosphorus concentration. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (1 listed)
- Serum creatinine
Key exclusion criteria (4 listed)
- Pregnancy
- No dietary intake interview
- Dietary intake interview not valid
- Answered the question "Have you had dialysis in the past year?" as "Yes"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Kidney function level
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2018.
- Background: PubMed 23302719Moore 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.
- Derived from this study: PubMed 26040641Moore 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.
- Individual participant dataSharing planned: Undecided. Plan to share data to be determined.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda W Moore, MS principal investigator
Director, Clinical Trials; Dept of Surgery
Questions about this trial
What is this clinical trial studying?
An observational study of Phosphorus Metabolism Disorders, run by Linda W. Moore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum phosphorus concentration (time frame: approximately 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02435017, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2018.