Dietary Sources of Sodium IntakeNCT02474693
Salt Sources Study
An observational study of Dietary Sources of Sodium Intake, run by Mary Cogswell.
Trial summary
The Centers for Disease Control and Prevention conducted an observational cross-sectional study to obtain information about the amount of sodium consumed from various sources (including sodium from processed and restaurant foods, sodium inherent in foods, and salt added at the table and during cooking) and to examine… Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Sources of Sodium Intake
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Dec 2014
- 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 18 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A convenience sample of adults aged 18-74 years, able to read and speak English, who have a telephone. Respondents will be excluded if they are pregnant, breastfeeding, have diabetes insipidus, or have chronic kidney disease. Information will be collected from the study participants in three study sites in Minnesota, Alabama, and California.
Who may be able to join
- able to read and speak English, who have a telephone
- live in one of three study sites in the following cities or surrounding geographic areas
- Minneapolis, Minnesota
- Birmingham, Alabama; Palo Alto, California
Who cannot join
- pregnant
- breastfeeding
- have diabetes insipidus
- have chronic kidney disease.
About this study
Official title: Assessment of the Proportion of Sodium Intake From a Variety of Sources - Salt Sources Study
The Centers for Disease Control and Prevention conducted an observational cross-sectional study to obtain information about the amount of sodium consumed from various sources (including sodium from processed and restaurant foods, sodium inherent in foods, and salt added at the table and during cooking) and to examine variability across population subgroups. Data collection will include an observational component as well as a sub-study designed to refine the accuracy of estimates of total sodium intake and discretionary sodium intake.
Information was collected in three distinct geographic regions: 1) Minneapolis/St. Paul, Minnesota, 2) Birmingham, Alabama, and 3) Palo Alto, California. Over a two-year period, a study center in each location recruited 150 participants (total N=450). Overall, an approximately equal number of adults ages 18-74 years by approximately 10-year age groups in each sex-race group, including whites, blacks, Hispanics, and Asians. A sub-study was conducted among a subgroup of 150 of these participants (50 per site). University of Minnesota serves as a study coordinating center.
Read the detailed description
The Centers for Disease Control and Prevention conducted an observational cross-sectional study to obtain information about the amount of sodium consumed from various sources (including sodium from processed and restaurant foods, sodium inherent in foods, and salt added at the table and during cooking) and to examine variability across population subgroups. Data collection will include an observational component as well as a sub-study designed to refine the accuracy of estimates of total sodium intake and discretionary sodium intake.
Information was collected in three distinct geographic regions: 1) Minneapolis/St. Paul, Minnesota, 2) Birmingham, Alabama, and 3) Palo Alto, California. Over a two-year period, a study center in each location recruited 150 participants (total N=450). Overall, an approximately equal number of adults ages 18-74 years by approximately 10-year age groups in each sex-race group, including whites, blacks, Hispanics, and Asians. A sub-study was conducted among a subgroup of 150 of these participants (50 per site). University of Minnesota serves as a study coordinating center.
After informed consent and completing a screening process, each participant completed a personal questionnaire, a tap water questionnaire, four 24-hour dietary recalls, and four qualitative food records. In addition, height and weight information on each participant were collected, and each participant collected duplicate portions of their cooking/table salt. A few participants at each site also provided water samples analyzed to produce estimates of the amount of sodium in private sources of tap water.
The Salt Sources Study also included a sub-study to help determine the accuracy of estimates of total sodium intake and discretionary salt intake. About 25 participants at each site used a Study Salt for 11 days instead of their own household salt, provide additional information based on four 24-hour urine collections, four follow-up urine collection questionnaires, and three follow-up questionnaires on Study Salt use. The Study Salt has the same amount of sodium and contains a very small amount of lithium, a metal found in trace amounts in all plants and animals and excreted in urine. Participants are instructed to use the study salt as they would their salt at home and to collect duplicate samples of the amount used at the table and during home cooking. The amount of lithium excreted in the 24-hour urine collection is measured to assess the amount of sodium consumed from discretionary salt use (salt used at the table and during home cooking).
Results from the Salt Sources Study will be used to inform public health strategies to reduce sodium intake, determine if substantial variability in sources of sodium intake exists by social and demographic subgroups, and better inform estimates of salt added at the table used in Healthy People 2020 objectives related to sodium reduction.
- Conditions
- Dietary Sources of Sodium Intake
What is being measured
The primary outcome is the main question the study is designed to answer.
Sodium intake as assessed through four 24 hour dietary recalls
Four 24-hour dietary recalls and duplicate collection of salt added at the table
Measured: 11 days
Secondary outcomes (3)
Discretionary sodium intake from salt added at the table and during cooking as assessed through duplicate salt collection
Collection of duplicated samples of salt added at the table and during cooking on 24-h diet recall days
Measured: 11 days
Total sodium intake as assessed through laboratory analysis 24-h urine collections
Measured from four 24-hour urine collections in a subset of 150 study participants
Measured: 11 days
Discretionary sodium intake (from salt added at the table or during cooking) assessed from the amount of lithium excreted in 24-hour urine collections.
Measured from 24-hour urine collections in a subset of 150 study participants who used lithium labeled salt at the table and for home cooking in place of their usual salt
Measured: 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study startJan 2014
- Primary completionDec 2014
- Study completionDec 2014
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 Dietary Sources of Sodium IntakeStudies 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
- Time perspective
- Cross-sectional
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mary Cogswell
- Sponsor type
- US federal agency
- Collaborators
- University of Minnesota, University of Birmingham, Stanford University
- Responsible party
- Sponsor-investigator, Mary Cogswell, Centers for Disease Control and Prevention
- Investigators
- Lyn Steffen, PhD, MPH, RD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474693
- Sponsor's protocol ID
- 0920-0982
- Status last verified
- Jan 2016
- First submitted
- 12 May 2015
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: When data cleaning is completed, data can be obtained through submission of a proposal to the proposal and publication committee through contacting one of the investigators
Publications
Quader ZS, Zhao L, Harnack LJ, Gardner CD, Shikany JM, Steffen LM, Gillespie C, Moshfegh A, Cogswell ME. Self-Reported Measures of Discretionary Salt Use Accurately Estimated Sodium Intake Overall but not in Certain Subgroups of US Adults from 3 Geographic Regions in the Salt Sources Study. J Nutr. 2019 Sep 1;149(9):1623-1632. doi: 10.1093/jn/nxz110.
PubMed 31179499Harnack LJ, Cogswell ME, Shikany JM, Gardner CD, Gillespie C, Loria CM, Zhou X, Yuan K, Steffen LM. Sources of Sodium in US Adults From 3 Geographic Regions. Circulation. 2017 May 9;135(19):1775-1783. doi: 10.1161/CIRCULATIONAHA.116.024446.
PubMed 28483828
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Proportion of Sodium Intake From a Variety of Sources - Salt Sources Study
- ClinicalTrials.gov ID
- NCT02474693
- Acronym / sponsor ID
- 0920-0982
- Conditions
- Dietary Sources of Sodium Intake
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Mary CogswellUS federal agency
- Collaborators
- University of Minnesota, University of Birmingham, Stanford University
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 18 Jun 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.
The Centers for Disease Control and Prevention conducted an observational cross-sectional study to obtain information about the amount of sodium consumed from various sources (including sodium from processed and restaurant foods, sodium inherent in foods, and salt added at the table and during cooking) and to examine variability across population subgroups. Data collection will include an observational component as well as a sub-study designed to refine the accuracy of estimates of total sodium intake and discretionary sodium intake.
Information was collected in three distinct geographic regions: 1) Minneapolis/St. Paul, Minnesota, 2) Birmingham, Alabama, and 3) Palo Alto, California. Over a two-year period, a study center in each location recruited 150 participants (total N=450). Overall, an approximately equal number of adults ages 18-74 years by approximately 10-year age groups in each sex-race group, including whites, blacks, Hispanics, and Asians. A sub-study was conducted among a subgroup of 150 of these participants (50 per site). University of Minnesota serves as a study coordinating center.
Detailed description
The Centers for Disease Control and Prevention conducted an observational cross-sectional study to obtain information about the amount of sodium consumed from various sources (including sodium from processed and restaurant foods, sodium inherent in foods, and salt added at the table and during cooking) and to examine variability across population subgroups. Data collection will include an observational component as well as a sub-study designed to refine the accuracy of estimates of total sodium intake and discretionary sodium intake.
Information was collected in three distinct geographic regions: 1) Minneapolis/St. Paul, Minnesota, 2) Birmingham, Alabama, and 3) Palo Alto, California. Over a two-year period, a study center in each location recruited 150 participants (total N=450). Overall, an approximately equal number of adults ages 18-74 years by approximately 10-year age groups in each sex-race group, including whites, blacks, Hispanics, and Asians. A sub-study was conducted among a subgroup of 150 of these participants (50 per site). University of Minnesota serves as a study coordinating center.
After informed consent and completing a screening process, each participant completed a personal questionnaire, a tap water questionnaire, four 24-hour dietary recalls, and four qualitative food records. In addition, height and weight information on each participant were collected, and each participant collected duplicate portions of their cooking/table salt. A few participants at each site also provided water samples analyzed to produce estimates of the amount of sodium in private sources of tap water.
The Salt Sources Study also included a sub-study to help determine the accuracy of estimates of total sodium intake and discretionary salt intake. About 25 participants at each site used a Study Salt for 11 days instead of their own household salt, provide additional information based on four 24-hour urine collections, four follow-up urine collection questionnaires, and three follow-up questionnaires on Study Salt use. The Study Salt has the same amount of sodium and contains a very small amount of lithium, a metal found in trace amounts in all plants and animals and excreted in urine. Participants are instructed to use the study salt as they would their salt at home and to collect duplicate samples of the amount used at the table and during home cooking. The amount of lithium excreted in the 24-hour urine collection is measured to assess the amount of sodium consumed from discretionary salt use (salt used at the table and during home cooking).
Results from the Salt Sources Study will be used to inform public health strategies to reduce sodium intake, determine if substantial variability in sources of sodium intake exists by social and demographic subgroups, and better inform estimates of salt added at the table used in Healthy People 2020 objectives related to sodium reduction.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A convenience sample of adults aged 18-74 years, able to read and speak English, who have a telephone. Respondents will be excluded if they are pregnant, breastfeeding, have diabetes insipidus, or have chronic kidney disease. Information will be collected from the study participants in three study sites in Minnesota, Alabama, and California.
Key inclusion criteria (4 listed)
- able to read and speak English, who have a telephone
- live in one of three study sites in the following cities or surrounding geographic areas
Key exclusion criteria (4 listed)
- pregnant
- breastfeeding
- have diabetes insipidus
- have chronic kidney disease.
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
Sodium intake as assessed through four 24 hour dietary recalls
Time frame: 11 days
Four 24-hour dietary recalls and duplicate collection of salt added at the table
3 secondary outcomes
Discretionary sodium intake from salt added at the table and during cooking as assessed through duplicate salt collection
Time frame: 11 days
Total sodium intake as assessed through laboratory analysis 24-h urine collections
Time frame: 11 days
Discretionary sodium intake (from salt added at the table or during cooking) assessed from the amount of lithium excreted in 24-hour urine collections.
Time frame: 11 days
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 28 Jan 2016.
- Derived from this study: PubMed 31179499Quader ZS, Zhao L, Harnack LJ, Gardner CD, Shikany JM, Steffen LM, Gillespie C, Moshfegh A, Cogswell ME. Self-Reported Measures of Discretionary Salt Use Accurately Estimated Sodium Intake Overall but not in Certain Subgroups of US Adults from 3 Geographic Regions in the Salt Sources Study. J Nutr. 2019 Sep 1;149(9):1623-1632. doi: 10.1093/jn/nxz110.
- Derived from this study: PubMed 28483828Harnack LJ, Cogswell ME, Shikany JM, Gardner CD, Gillespie C, Loria CM, Zhou X, Yuan K, Steffen LM. Sources of Sodium in US Adults From 3 Geographic Regions. Circulation. 2017 May 9;135(19):1775-1783. doi: 10.1161/CIRCULATIONAHA.116.024446.
- Study description, data collection forms and questionnaires included on the Office of Management and Budget websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. When data cleaning is completed, data can be obtained through submission of a proposal to the proposal and publication committee through contacting one of the investigators
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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.
Lyn Steffen, PhD, MPH, RD principal investigator
University of Minnesota
Questions about this trial
What is this clinical trial studying?
An observational study of Dietary Sources of Sodium Intake, run by Mary Cogswell.
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 4 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 28 Jan 2016. 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?
Sodium intake as assessed through four 24 hour dietary recalls (time frame: 11 days). 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 NCT02474693, 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 28 Jan 2016.