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

Not Applicable

Completed

• Conditions: Multiple Sclerosis; Rheumatoid Arthritis
• Interventions: Other: QALCIMUM questionnaire; Other: Determination of calcium intake by a dietician interview

• Registration Number: NCT02636829
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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

Study Timeline

• Study First Submitted: 2015-11-17
• Study First Submitted QC: 2015-12-17
• Study First Posted: 2015-12-22
• Study Start: 2016-03
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-14
• Last Update Posted: 2016-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rheumatoid Arthritis patients	QALCIMUM questionnaire	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
Multiple Sclerosis patients	QALCIMUM questionnaire	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
Multiple Sclerosis patients	Determination of calcium intake by a dietician interview	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
Rheumatoid Arthritis patients	Determination of calcium intake by a dietician interview	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

Primary Outcome Measures

Name	Time	Method
The QALCIMUM questionnaire	Day 0
Calcium intake (mg/day)	Day 0	As determined by a consultation with a dietician.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHRU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France