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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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26 September 2016 |
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Main ID: |
NCT02636829 |
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Date of registration:
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17/11/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Validation of Self-administered Questionnaire for Assessing Calcium Intake in Patients With Multiple Sclerosis or Chronic Inflammatory Arthritis
QALCIMUM |
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Scientific title:
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Validation of Self-administered Questionnaire Specifically for Assessing Calcium Intake (QALCIMUM®) in Patients With Multiple Sclerosis (MS) or Chronic Inflammatory Arthritis |
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Date of first enrolment:
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March 2016 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02636829 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Eric Thouvenot, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre Hospitalier Universitaire de Nîmes |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
69 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Rheumatoid Arthritis
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Intervention(s)
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Other: QALCIMUM questionnaire
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Other: Determination of calcium intake by a dietician interview
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Primary Outcome(s)
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Calcium intake (mg/day)
[Time Frame: Day 0]
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The QALCIMUM questionnaire
[Time Frame: Day 0]
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Secondary Outcome(s)
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Quality of Life questionnaire: TLS Coping
[Time Frame: Day 0]
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QALCIMUM questionnaire administration time (minutes)
[Time Frame: Day 0]
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Quality of Life questionnaire: TLSQOL10
[Time Frame: Day 0]
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Quality of Life questionnaire: MSIS29 (MS Impact Scale)
[Time Frame: Day 0]
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The FRAX questionnaire
[Time Frame: Day 0]
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The Vitamin D questionnaire
[Time Frame: Day 0]
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The GRIO questionnaire
[Time Frame: Day 0]
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Patient diet (qualitative)
[Time Frame: Day 0]
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Secondary ID(s)
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2015-A01033-46
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LOCAL/2015/ET-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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