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

Rheumatoid Arthritis Clinical Trial

— QALCIMUM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02636829
• Other study ID #: LOCAL/2015/ET-01
• Secondary ID: 2015-A01033-46
• Status: Completed
• Phase: N/A
• First received: November 17, 2015
• Last updated: September 14, 2016
• Start date: March 2016
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Multiple Sclerosis
• Rheumatoid Arthritis
• Sclerosis

Intervention

Other:
• QALCIMUM questionnaire
All patients will fill out the QALCIMUM questionnaire.
• 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.

Locations

Country	Name	City	State
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calcium intake (mg/day)	As determined by a consultation with a dietician.	Day 0	No
Primary	The QALCIMUM questionnaire		Day 0	No
Secondary	Patient diet (qualitative)	Patient diet classified as: normal; vegetarian, vegetalian; Seignalet; Kousmine; other.	Day 0	No
Secondary	QALCIMUM questionnaire administration time (minutes)		Day 0	No
Secondary	The GRIO questionnaire	GRIO = Osteoporosis Research and Information Group	Day 0	No
Secondary	The FRAX questionnaire	FRAX = WHO Fracture RISK Assessment Tool	Day 0	No
Secondary	Quality of Life questionnaire: MSIS29 (MS Impact Scale)		Day 0	No
Secondary	Quality of Life questionnaire: TLSQOL10		Day 0	No
Secondary	Quality of Life questionnaire: TLS Coping		Day 0	No
Secondary	The Vitamin D questionnaire		Day 0	No