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

NCT02636829 | Completed

• 2 other identifiers: LOCAL/2015/ET-012015-A01033-46
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• Calcium intake (mg/day)

  As determined by a consultation with a dietician.

  Day 0

• The QALCIMUM questionnaire

  Day 0

Secondary Outcomes (8)

• Patient diet (qualitative)

  Day 0

• QALCIMUM questionnaire administration time (minutes)

  Day 0

• The GRIO questionnaire

  Day 0

• The FRAX questionnaire

  Day 0

• Quality of Life questionnaire: MSIS29 (MS Impact Scale)

  Day 0

Study Arms (2)

Multiple Sclerosis patients

EXPERIMENTAL

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; Other: Determination of calcium intake by a dietician interview

Rheumatoid Arthritis patients

EXPERIMENTAL

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; Other: Determination of calcium intake by a dietician interview

Interventions

QALCIMUM questionnaire OTHER

All patients will fill out the QALCIMUM questionnaire.

Multiple Sclerosis patients; Rheumatoid Arthritis patients

Determination of calcium intake by a dietician interview OTHER

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.

Multiple Sclerosis patients; Rheumatoid Arthritis patients

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Multiple Sclerosis; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Eric Thouvenot, MD, PhD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2015
• First Posted: December 22, 2015
• Study Start: March 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 15, 2016

Record last verified: 2016-09

Locations

FR (1)