NCT00512733

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

1 active site

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

March 1, 2006

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 8, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

August 11, 2014

Status Verified

August 1, 2014

Enrollment Period

2 years

First QC Date

August 7, 2007

Last Update Submit

August 8, 2014

Conditions

Keywords

Healthy volunteers

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 days

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults

You may qualify if:

  • Independently living women over the age of 19 in generally good health.

You may not qualify if:

  • Inability to keep a diet record
  • Active gastrointestinal disease that limits or restricts diet
  • Inability to understand and provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco

San Francisco, California, 94115, United States

Location

Study Officials

  • Deborah Sellmeyer, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2007

First Posted

August 8, 2007

Study Start

March 1, 2006

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

August 11, 2014

Record last verified: 2014-08

Locations