Back to resultsValidation of Self-administered Questionnaire for Assessing Calcium Intake in Patients With Multiple Sclerosis or Chronic Inflammatory Arthritis (QALCIMUM)
Primary Purpose
Multiple Sclerosis, Rheumatoid Arthritis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
QALCIMUM questionnaire
Determination of calcium intake by a dietician interview
Sponsored by
About this trial
This is an interventional diagnostic trial for Multiple Sclerosis
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
Sites / Locations
- CHRU de Nîmes - Hôpital Universitaire Carémeau
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Multiple Sclerosis patients
Rheumatoid Arthritis patients
Arm Description
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
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
Outcomes
Primary Outcome Measures
Calcium intake (mg/day)
As determined by a consultation with a dietician.
The QALCIMUM questionnaire
Secondary Outcome Measures
Patient diet (qualitative)
Patient diet classified as: normal; vegetarian, vegetalian; Seignalet; Kousmine; other.
QALCIMUM questionnaire administration time (minutes)
The GRIO questionnaire
GRIO = Osteoporosis Research and Information Group
The FRAX questionnaire
FRAX = WHO Fracture RISK Assessment Tool
Quality of Life questionnaire: MSIS29 (MS Impact Scale)
Quality of Life questionnaire: TLSQOL10
Quality of Life questionnaire: TLS Coping
The Vitamin D questionnaire
Full Information
NCT ID
NCT02636829
First Posted
November 17, 2015
Last Updated
September 14, 2016
Sponsor
Centre Hospitalier Universitaire de Nīmes
1. Study Identification
Unique Protocol Identification Number
NCT02636829
Brief Title
Validation of Self-administered Questionnaire for Assessing Calcium Intake in Patients With Multiple Sclerosis or Chronic Inflammatory Arthritis
Acronym
QALCIMUM
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
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Rheumatoid Arthritis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multiple Sclerosis patients
Arm Type
Experimental
Arm Description
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
Arm Title
Rheumatoid Arthritis patients
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
QALCIMUM questionnaire
Intervention Description
All patients will fill out the QALCIMUM questionnaire.
Intervention Type
Other
Intervention Name(s)
Determination of calcium intake by a dietician interview
Intervention Description
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.
Primary Outcome Measure Information:
Title
Calcium intake (mg/day)
Description
As determined by a consultation with a dietician.
Time Frame
Day 0
Title
The QALCIMUM questionnaire
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Patient diet (qualitative)
Description
Patient diet classified as: normal; vegetarian, vegetalian; Seignalet; Kousmine; other.
Time Frame
Day 0
Title
QALCIMUM questionnaire administration time (minutes)
Time Frame
Day 0
Title
The GRIO questionnaire
Description
GRIO = Osteoporosis Research and Information Group
Time Frame
Day 0
Title
The FRAX questionnaire
Description
FRAX = WHO Fracture RISK Assessment Tool
Time Frame
Day 0
Title
Quality of Life questionnaire: MSIS29 (MS Impact Scale)
Time Frame
Day 0
Title
Quality of Life questionnaire: TLSQOL10
Time Frame
Day 0
Title
Quality of Life questionnaire: TLS Coping
Time Frame
Day 0
Title
The Vitamin D questionnaire
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Thouvenot, MD, PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes Cedex 09
ZIP/Postal Code
30029
Country
France
12. IPD Sharing Statement
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Validation of Self-administered Questionnaire for Assessing Calcium Intake in Patients With Multiple Sclerosis or Chronic Inflammatory Arthritis
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