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

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Rheumatoid Arthritis
• Intervention / Treatment: Other: QALCIMUM questionnaire; Other: Determination of calcium intake by a dietician interview

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes Cedex 09, France, 30029
    • CHRU de Nîmes - Hôpital Universitaire Carémeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Multiple Sclerosis patients; 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; All patients will fill out the QALCIMUM questionnaire.; Other: Determination of calcium intake by a dietician interview; 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.
EXPERIMENTAL: Rheumatoid Arthritis patients; 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; All patients will fill out the QALCIMUM questionnaire.; Other: Determination of calcium intake by a dietician interview; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (ACTUAL): August 1, 2016
• Study Completion (ACTUAL): August 1, 2016

Study Registration Dates

• First Submitted: November 17, 2015
• First Submitted That Met QC Criteria: December 17, 2015
• First Posted (ESTIMATE): December 22, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): September 15, 2016
• Last Update Submitted That Met QC Criteria: September 14, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Multiple Sclerosis; Sclerosis; Arthritis; Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Calcium
• Other Study ID Numbers: LOCAL/2015/ET-01; 2015-A01033-46 (OTHER: RCB number)