HealthyNCT00512733
Validation of Dietary Calcium Questionnaires Using Diet Records
An observational study of Healthy, run by University of California, San Francisco at 1 site in United States.
Trial summary
Dairy products continue to be an important source of calcium, providing over half the calcium intake for most individuals. Educational interventions promoting adequate calcium intake with tools estimating dietary calcium that can be easily utilized by consumers would be a valuable asset to promoting skeletal health. Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Mar 2008
- 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 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults
Who may be able to join
- Independently living women over the age of 19 in generally good health.
Who cannot join
- Inability to keep a diet record
- Active gastrointestinal disease that limits or restricts diet
- Inability to understand and provide informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94115
About this study
Dairy products continue to be an important source of calcium, providing over half the calcium intake for most individuals. Educational interventions promoting adequate calcium intake with tools estimating dietary calcium that can be easily utilized by consumers would be a valuable asset to promoting skeletal health. Validation of these tools against standard dietary assessment methods enhances their utility. The Dairy Council of California has developed two dietary calcium questionnaires, one electronic and one in print, using known dietary sources of calcium including frequency of consumption and portion size. For these questionnaires to be effective in clinical and research settings they must be a valid measurement of dietary calcium intake. To measure the validity of the dietary calcium questionnaires one hundred seventy three women will complete the two dietary calcium questionnaires and one 3-day food record. The dietary calcium questionnaires will be validated against this established method of dietary intake measurement. The objective of this study is to validate two dietary calcium questionnaires that can be used in clinical and research settings against an established method of dietary intake measurement. It is hypothesized that both dietary calcium questionnaires will be a valid measurement of dietary calcium intake in women.
Read the detailed description
The Dairy Council of California has developed two dietary calcium questionnaires, one electronic and one in print, using known dietary sources of calcium including frequency of consumption and portion size. For these questionnaires to be effective in clinical and research settings they must be a valid measurement of dietary calcium intake. To measure the validity of the dietary calcium questionnaires one hundred seventy three women will complete the two dietary calcium questionnaires and one 3-day food record. The dietary calcium questionnaires will be validated against this established method of dietary intake measurement. The objective of this study is to validate two dietary calcium questionnaires that can be used in clinical and research settings against an established method of dietary intake measurement.
- Conditions
- Healthy
- Keywords
- Healthy volunteers
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean calcium intake
Participants' 3-day food records were mailed to the study and examined for completeness and legibility. Missing or unclear items were corrected by telephoning the participant. Food records were entered into Food Processor Plus software (ESHA Research, Salem, OR) to determine nutrient content. For food items that were not in the software's database, nutrient content was determined by examination of labels, contact with food manufacturers, search of the US Department of Agriculture nutrient database, or estimation from ingredient content by an RD.
At the initial study visit, participants completed a written questionnaire and the online questionnaire. Calcium intake was calculated using a built-in calculator in the online questionnaire and by hand using the instructions in the booklet for the written questionnaire.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2007 (estimated)
- Study startMar 2006
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Dairy Council of California
- Responsible party
- Sponsor
- Investigators
- Deborah Sellmeyer, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00512733
- Sponsor's protocol ID
- H9291-26992
- Status last verified
- Aug 2014
- First submitted
- 7 Aug 2007
- Last updated
- 11 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Dietary Calcium Questionnaires Using Diet Records
- ClinicalTrials.gov ID
- NCT00512733
- Acronym / sponsor ID
- H9291-26992
- Conditions
- Healthy
- Keywords
- Healthy volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Dairy Council of California
- Study start
- Mar 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 8 Aug 2007 (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.
Dairy products continue to be an important source of calcium, providing over half the calcium intake for most individuals. Educational interventions promoting adequate calcium intake with tools estimating dietary calcium that can be easily utilized by consumers would be a valuable asset to promoting skeletal health. Validation of these tools against standard dietary assessment methods enhances their utility. The Dairy Council of California has developed two dietary calcium questionnaires, one electronic and one in print, using known dietary sources of calcium including frequency of consumption and portion size. For these questionnaires to be effective in clinical and research settings they must be a valid measurement of dietary calcium intake. To measure the validity of the dietary calcium questionnaires one hundred seventy three women will complete the two dietary calcium questionnaires and one 3-day food record. The dietary calcium questionnaires will be validated against this established method of dietary intake measurement. The objective of this study is to validate two dietary calcium questionnaires that can be used in clinical and research settings against an established method of dietary intake measurement. It is hypothesized that both dietary calcium questionnaires will be a valid measurement of dietary calcium intake in women.
Detailed description
The Dairy Council of California has developed two dietary calcium questionnaires, one electronic and one in print, using known dietary sources of calcium including frequency of consumption and portion size. For these questionnaires to be effective in clinical and research settings they must be a valid measurement of dietary calcium intake. To measure the validity of the dietary calcium questionnaires one hundred seventy three women will complete the two dietary calcium questionnaires and one 3-day food record. The dietary calcium questionnaires will be validated against this established method of dietary intake measurement. The objective of this study is to validate two dietary calcium questionnaires that can be used in clinical and research settings against an established method of dietary intake measurement.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults
Key inclusion criteria (1 listed)
- Independently living women over the age of 19 in generally good health.
Key exclusion criteria (3 listed)
- Inability to keep a diet record
- Active gastrointestinal disease that limits or restricts diet
- Inability to understand and provide informed consent.
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
Mean calcium intake
Time frame: 3 days
Participants' 3-day food records were mailed to the study and examined for completeness and legibility. Missing or unclear items were corrected by telephoning the participant. Food records were entered into Food Processor Plus software (ESHA Research, Salem, OR) to determine nutrient content. For food items that were not in the software's database, nutrient content was determined by examination of labels, contact with food manufacturers, search of the US Department of Agriculture nutrient database, or estimation from ingredient content by an RD. At the initial study visit, participants completed a written questionnaire and the online questionnaire. Calcium intake was calculated using a built-in calculator in the online questionnaire and by hand using the instructions in the booklet for the written questionnaire.
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 11 Aug 2014.
Related trials for Healthy
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Digestive Health, Quality of Life
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
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.
Deborah Sellmeyer, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by University of California, San Francisco at 1 site in United States.
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 3 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 11 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Mean calcium intake (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2014.