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
|Condition or disease||Intervention/treatment|
|Osteoporosis Nutrition||Other: Full length Block 2014 Food Frequency Questionnaire Other: Revised Calcium, Vitamin D and Protein Screener|
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.
|Study Type :||Observational|
|Estimated Enrollment :||45 participants|
|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|
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
- Agreement of the 2 FFQs on protein intake [ Time Frame: 1 year ]Protein intake will be assessed with 2 different methods
- Agreement of the 2 FFQs on calcium intake [ Time Frame: 1 year ]Calcium intake will be assessed with 2 different methods
- Agreement of the 2 FFQs on vitamin D intake [ Time Frame: 1 year ]Vitamin D intake will be assessed with 2 different methods
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
|Contact: Laura AG Armas, MD,MSfirstname.lastname@example.org|
|United States, Nebraska|
|University of Nebraska||Recruiting|
|Omaha, Nebraska, United States|
|Contact: Laura AG Armas, MD,MS 402-559-6310|
|Principal Investigator:||Laura AG Armas, MD,MS||University of Nebraska|