Validation of Self-administered Questionnaire for Assessing Calcium Intake in Patients With Multiple Sclerosis or Chronic Inflammatory Arthritis

Study Overview
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Brief Summary
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The main objective of this study is to measure, in patients with MS or Chronic Inflammatory Arthritis (CIA), the correlation between two calcium intake assessment methods: A self assessment questionnaire of calcium intake (QALCIMUM®) versus a food survey serving as a reference (gold standard) and based on data from CIQUAL *. * CIQUAL Data: Nutritional food composition table available on the website of the ANSES (National Agency for Sanitary Security of Food, Environment and Labour), published by the Observatory of the Nutritional Quality of Foods. This table includes 1500 sheets of 58 nutritional components. The data is integrated into the software (DATAMEAL) for calculating the ingesta parameters at the Nîmes University Hospital.

Detailed Description
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The secondary objectives of this study are: A. To estimate the average calcium intake and variability in a population of MS patients and the proportion of patients at risk for osteoporosis. B. To estimate the average calcium intake and variability in a population of CIA patients and the proportion of patients at risk for osteoporosis. C. To describe the dietary changes observed in MS or CIA patients . D. To estimate the administration time of the QALCIMUM® self-questionnaire. E. Estimate calcium intake means and variability in a population of patients with MS or CIA and the proportion of patients at risk of osteoporotic fracture F. To assess the quality of life of patients with MS or CIA G. To evaluate endogenous mean vitamin D production in a population of patients with MS or CIA

Official Title
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Validation of Self-administered Questionnaire Specifically for Assessing Calcium Intake (QALCIMUM®) in Patients With Multiple Sclerosis (MS) or Chronic Inflammatory Arthritis

Conditions
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Multiple Sclerosis, Rheumatoid Arthritis

Intervention / Treatment
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* Other: QALCIMUM questionnaire
* Other: Determination of calcium intake by a dietician interview


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient must have given his/her informed and signed consent The patient must be insured or beneficiary of a health insurance plan Patient with confirmed diagnosis of multiple sclerosis or chronic inflammatory arthritis (rheumatoid arthritis, spondyloarthritis, psoriatic arthritis) Exclusion Criteria: The patient is participating in another biomedical research study The patient has participated in another biomedical research study in the past 3 months The patient is in an exclusion period determined by a previous study The patient is under judicial protection, or under guardianship The patient refuses to sign the consent It is impossible to correctly inform the patient The subject is not able to complete a self-administered questionnaire

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multiple Sclerosis patients<br>Patients (Multiple Sclerosis, Rheumatoid Arthritis) will be recruited during specialized consultations or hospital admissions for monitoring their chronic disease at the University Hospital of Nimes and will be divided into two distinct groups. Intervention: QALCIMUM questionnaire Intervention: Determination of calcium intake by a dietician interview | Other: QALCIMUM questionnaire<br>* All patients will fill out the QALCIMUM questionnaire.<br>Other: Determination of calcium intake by a dietician interview<br>* All patients will have an interview with a dietician who performs a food survey serving as a reference (gold standard) and based on data from CIQUAL *. * CIQUAL Data: Nutritional food composition table available on the website of the ANSES (National Agency for Sanitary Security of Food, Environment and Labour), published by the Observatory of the Nutritional Quality of Foods. This table includes 1500 sheets of 58 nutritional components. The data is integrated into the software (DATAMEAL) for calculating the ingesta parameters at the Nîmes University Hospital.<br>|
| Experimental: Rheumatoid Arthritis patients<br>Patients (Multiple Sclerosis, Rheumatoid Arthritis) will be recruited during specialized consultations or hospital admissions for monitoring their chronic disease at the University Hospital of Nimes and will be divided into two distinct groups. Intervention: QALCIMUM questionnaire Intervention: Determination of calcium intake by a dietician interview | Other: QALCIMUM questionnaire<br>* All patients will fill out the QALCIMUM questionnaire.<br>Other: Determination of calcium intake by a dietician interview<br>* All patients will have an interview with a dietician who performs a food survey serving as a reference (gold standard) and based on data from CIQUAL *. * CIQUAL Data: Nutritional food composition table available on the website of the ANSES (National Agency for Sanitary Security of Food, Environment and Labour), published by the Observatory of the Nutritional Quality of Foods. This table includes 1500 sheets of 58 nutritional components. The data is integrated into the software (DATAMEAL) for calculating the ingesta parameters at the Nîmes University Hospital.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calcium intake (mg/day) | As determined by a consultation with a dietician. | Day 0 | 
| The QALCIMUM questionnaire |  | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient diet (qualitative) | Patient diet classified as: normal; vegetarian, vegetalian; Seignalet; Kousmine; other. | Day 0 | 
| QALCIMUM questionnaire administration time (minutes) |  | Day 0 | 
| The GRIO questionnaire | GRIO = Osteoporosis Research and Information Group | Day 0 | 
| The FRAX questionnaire | FRAX = WHO Fracture RISK Assessment Tool | Day 0 | 
| Quality of Life questionnaire: MSIS29 (MS Impact Scale) |  | Day 0 | 
| Quality of Life questionnaire: TLSQOL10 |  | Day 0 | 
| Quality of Life questionnaire: TLS Coping |  | Day 0 | 
| The Vitamin D questionnaire |  | Day 0 |