Clinical trial NCT02636829: Validation of Self-administered Questionnaire for Assessing Calcium Intake in Patients With Multiple Sclerosis or Chronic Inflammatory Arthritis
Official title: Validation of Self-administered Questionnaire Specifically for Assessing Calcium Intake (QALCIMUM®) in Patients With Multiple Sclerosis (MS) or Chronic Inflammatory Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Rheumatoid Arthritis
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2015-12-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Calcium intake (mg/day)
timeFrame: Day 0
measure: The QALCIMUM questionnaire
timeFrame: Day 0
Secondary outcomes:
measure: Patient diet (qualitative)
timeFrame: Day 0
measure: QALCIMUM questionnaire administration time (minutes)
timeFrame: Day 0
measure: The GRIO questionnaire
timeFrame: Day 0
measure: The FRAX questionnaire
timeFrame: Day 0
measure: Quality of Life questionnaire: MSIS29 (MS Impact Scale)
timeFrame: Day 0
measure: Quality of Life questionnaire: TLSQOL10
timeFrame: Day 0
measure: Quality of Life questionnaire: TLS Coping
timeFrame: Day 0
measure: The Vitamin D questionnaire
timeFrame: Day 0
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Eric Thouvenot, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: