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Validation of a Revised Food Frequency Questionnaire (FFQ)

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ClinicalTrials.gov Identifier: NCT02693184
Recruitment Status : Recruiting
First Posted : February 26, 2016
Last Update Posted : February 21, 2018
Sponsor:
Information provided by (Responsible Party):
Laura Armas MD, MS, University of Nebraska

Brief Summary:
The purpose of this study is to validate a revised food frequency questionnaire that is designed to capture vitamin D, calcium and protein intake in a population of elderly men and women with fragility fractures. Protein, calcium and protein intake will be correlated with biochemical measures and bone mineral density measured by DXA.

Condition or disease Intervention/treatment
Osteoporosis Nutrition Other: Full length Block 2014 Food Frequency Questionnaire Other: Revised Calcium, Vitamin D and Protein Screener

Detailed Description:

The purpose of this study is to validate a revised food frequency questionnaire that is designed to capture vitamin D, calcium and protein intake in a population of elderly men and women with fragility fractures. Protein, calcium and protein intake will be correlated with biochemical measures and bone mineral density measured by DXA.

Eligibility Criteria) Forty-five eligible participants will be recruited from the endocrine referrals for osteoporosis/fracture. They will be men and women, age >65 years with a fragility fracture (defined as a fracture sustained after a fall from a standing height or less). They will be English speaking. They will need to have the mental capacity to recall events, (MMSE score ³24).11 They will need to have a telephone and the ability to answer questions over a phone. They will not have secondary causes of fragility fracture such as malabsorption (celiac disease, bariatric surgery), liver disease, organ transplant, hyperparathyroidism, multiple myeloma, current cancer diagnosis, or alcoholism. They will not have renal disease requiring dialysis (as the dietary requirement of these patients is quite different from the general elderly population). They will not be on tubefeeds of any kind (although supplemental food such as Ensure is allowed). Interventions and Evaluations) The evaluations will include a history and physical exam, and a mini mental status exam. Two telephone interviews will be conducted ~ 4 weeks apart during which the Block 2014 questionnaire will be given and the revised screener will be given. The order that the questionnaires are given will be randomized. As part of the standard of care workup for osteoporosis, a biochemical workup including 25-hydroxyvitamin D, comprehensive metabolic profile, bone specific alkaline phosphatase (a bone remodeling marker), phosphorus and transglutaminase IgA (to rule out celiac disease), and DXA scan for bone mineral density (BMD) measurement will be done. The BMD by DXA and 25-hydroxyvitamin D will be correlated to protein, calcium and vitamin D intake obtained by the Block 2014.


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Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Validation of a Revised Food Frequency Questionnaire in a Population of Elderly Men and Women With Fragility Fractures and Correlation With Bone Mineral Density and Biochemical Markers
Actual Study Start Date : March 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures Vitamin D

Group/Cohort Intervention/treatment
Fragility Fracture Case
Men and women, age >65 years with a fragility fracture (defined as a fracture sustained after a fall from a standing height or less).
Other: Full length Block 2014 Food Frequency Questionnaire
The food and beverage list includes 127 items, plus additional questions to adjust for fat, protein, carbohydrate, sugar, and whole grain content.

Other: Revised Calcium, Vitamin D and Protein Screener
The food list includes 29 food items and 5 supplements




Primary Outcome Measures :
  1. Agreement of the 2 FFQs on protein intake [ Time Frame: 1 year ]
    Protein intake will be assessed with 2 different methods

  2. Agreement of the 2 FFQs on calcium intake [ Time Frame: 1 year ]
    Calcium intake will be assessed with 2 different methods

  3. Agreement of the 2 FFQs on vitamin D intake [ Time Frame: 1 year ]
    Vitamin D intake will be assessed with 2 different methods



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men and women, age >65 years with a fragility fracture (defined as a fracture sustained after a fall from a standing height or less).
Criteria

Inclusion Criteria:

  • They will be men and women, age >65 years with a fragility fracture (defined as a fracture sustained after a fall from a standing height or less). They will be English speaking. They will need to have the mental capacity to recall events, (MMSE score >24).11 They will need to have a telephone and the ability to answer questions over a phone.

Exclusion Criteria:

  • They will not have secondary causes of fragility fracture such as malabsorption (celiac disease, bariatric surgery), liver disease, organ transplant, hyperparathyroidism, multiple myeloma, current cancer diagnosis, or alcoholism. They will not have renal disease requiring dialysis (as the dietary requirement of these patients is quite different from the general elderly population). They will not be on tubefeeds of any kind (although supplemental food such as Ensure is allowed).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02693184


Contacts
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Contact: Laura AG Armas, MD,MS 402-559-6310 laura.armas@unmc.edu

Locations
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United States, Nebraska
University of Nebraska Recruiting
Omaha, Nebraska, United States
Contact: Laura AG Armas, MD,MS    402-559-6310      
Sponsors and Collaborators
University of Nebraska
Investigators
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Principal Investigator: Laura AG Armas, MD,MS University of Nebraska

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Responsible Party: Laura Armas MD, MS, Associate Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT02693184     History of Changes
Other Study ID Numbers: 117-16
First Posted: February 26, 2016    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The participant will be sent a letter at the end of study detailing their calcium, protein and vitamin D intake reported on the FFQ

Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamin D
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents