Osteoporosis In Non-Celiac Wheat Sensitivity Patients
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|ClinicalTrials.gov Identifier: NCT02421783|
Recruitment Status : Recruiting
First Posted : April 21, 2015
Last Update Posted : September 5, 2018
Non-celiac gluten sensitivity (NCGS) or 'wheat sensitivity' (NCWS) is included in the spectrum of gluten-related disorders. No data are available on the prevalence of low bone mass density (BMD) in NCWS. Our study aims to evaluate the prevalence of low BMD in NCWS patients and search for correlations with other clinical characteristics.
This prospective observation study will include 90 NCWS patients with irritable bowel syndrome (IBS)-like symptoms, 90 IBS and 90 celiac controls. Patients will be recruited at the Internal Medicine and at the Gastroenterology Units of the University of Palermo. Elimination diet and double-blind placebo controlled (DBPC) wheat challenge proved the NCWS diagnosis. All subjects underwent BMD assessment by Dual Energy X-Ray Absorptiometry (DXA), duodenal histology, Human Leukocyte Antigen (HLA) DQ typing, body mass index (BMI) evaluation and assessment for daily calcium intake.
|Condition or disease|
|Non-celiac Wheat Sensitivity|
|Study Type :||Observational|
|Estimated Enrollment :||270 participants|
|Official Title:||Osteoporosis In Non-Celiac Wheat Sensitivity Patients|
|Actual Study Start Date :||May 2015|
|Actual Primary Completion Date :||October 2016|
|Estimated Study Completion Date :||June 2019|
Consecutive adult patients with an irritable bowel syndrome (IBS)-like clinical presentation, according to Rome II criteria, and a definitive diagnosis of NCWS.
Sex- and age-matched subjects with CD, diagnosed according to standard criteria during the same study period and enrolled as first control group
Sex- and age-matched subjects with IBS unrelated to NCWS or other food 'intolerance', diagnosed according to standard criteria during the same study period and enrolled as second control group
- Change in bone mineral density (BMD) [ Time Frame: At baseline and at 24 months ]BMD will be assessed by dual x-ray absorptiometry (DXA), using a QDR Discovery Hologic DXA scanner in the femoral neck and in the lumbar spine. For each scan, BMD and T-scores will be recorded. A T-score between +1 and -1 is considered normal, between -1 and -2.5 indicates osteopenia, -2.5 or lower indicates osteoporosis. The investigators also will calculate the 10-year fracture risks according to the standardized WHO FRAX equation, computed with BMD (T-score) at the femoral neck.
- Conventional lateral spine x-ray as an assessment of suspected osteoporotic vertebral fractures, using Genant's method [ Time Frame: At baseline ]A random sample of the patients and controls will undergo conventional lateral spine x-ray for better assessment of suspected osteoporotic vertebral fractures, according to Genant's method (grade 0, no reduction; grade 1, minimal fracture, 20-25% vertebral height decrease; grade 2, moderate fracture, 25-40% vertebral height decrease; and grade 3, severe fracture, greater than 40% vertebral height decrease).
- Change in serum bone alkaline phosphatase [ Time Frame: At baseline and at 24 months ]Serum bone alkaline phosphatase values will be detected (refences values of adults males < or =20 mcg/L; of adults premenopausal females < or =14 mcg/L; of adults postmenopausal females < or =22 mcg/L).
- Change in serum 25-hydroxyvitamin D [ Time Frame: At baseline and at 24 months ]Serum 25-hydroxyvitamin D values will be detected (refences values 30.0-74.0 ng/mL).
- Change in serum phosphorus levels [ Time Frame: At baseline and at 24 months ]Serum phosphorus levels values will be detected (refences values of subjects > or =18 years: 2.5-4.5 mg/dL).
- Change in serum calcium levels [ Time Frame: At baseline and at 24 months ]Serum calcium levels values will be detected (refences values of males age 18-21 years: 9.3-10.3 mg/dL, age 22 years and older: 8.9-10.1 mg/dL; of females age 18 years and older: 8.9-10.1 mg/dL)
- Change in urinary phosphorus levels [ Time Frame: At baseline and at 24 months ]Urinary phosphorus levels values will be detected (refences values 0.4-1.3 g per 24-hour urine sample).
- Change in urinary calcium levels [ Time Frame: At baseline and at 24 months ]Urinary calcium levels values will be detected (refences values 100-300 mg per 24-hour urine sample).
- Change in dietary intake and lifestyle [ Time Frame: At baseline and at 24 months ]All the participants will fill in a health and lifestyle questionnaire, considering menarche and age at menopause (if applicable), medical and drug abuse history, lifestyle habits (including elimination diet, smoking status, alcohol consumption, Italian espresso coffee drinking and physical activity); history of bone fractures will also be recorded. In order to assess daily caloric intake and calcium intake, the subjects will receive a dietary form containing a printed list of the most common foods.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02421783
|Contact: Pasquale Mansueto, MD||+39 firstname.lastname@example.org|
|Sciacca, Agrigento, Italy|
|Palermo, Italy, 90127|
|Study Director:||Antonio Carroccio, PhD||Department of Internal Medicine, Giovanni Paolo II Hospital, Via Pompei, Sciacca, Italy|