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Trial record 40 of 43 for:    "multiple sclerosis" AND "vitamin D"

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

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ClinicalTrials.gov Identifier: NCT02636829
Recruitment Status : Completed
First Posted : December 22, 2015
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Rheumatoid Arthritis Other: QALCIMUM questionnaire Other: Determination of calcium intake by a dietician interview Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Validation of Self-administered Questionnaire Specifically for Assessing Calcium Intake (QALCIMUM®) in Patients With Multiple Sclerosis (MS) or Chronic Inflammatory Arthritis
Study Start Date : March 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


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.





Primary Outcome Measures :
  1. Calcium intake (mg/day) [ Time Frame: Day 0 ]
    As determined by a consultation with a dietician.

  2. The QALCIMUM questionnaire [ Time Frame: Day 0 ]

Secondary Outcome Measures :
  1. Patient diet (qualitative) [ Time Frame: Day 0 ]
    Patient diet classified as: normal; vegetarian, vegetalian; Seignalet; Kousmine; other.

  2. QALCIMUM questionnaire administration time (minutes) [ Time Frame: Day 0 ]
  3. The GRIO questionnaire [ Time Frame: Day 0 ]
    GRIO = Osteoporosis Research and Information Group

  4. The FRAX questionnaire [ Time Frame: Day 0 ]
    FRAX = WHO Fracture RISK Assessment Tool

  5. Quality of Life questionnaire: MSIS29 (MS Impact Scale) [ Time Frame: Day 0 ]
  6. Quality of Life questionnaire: TLSQOL10 [ Time Frame: Day 0 ]
  7. Quality of Life questionnaire: TLS Coping [ Time Frame: Day 0 ]
  8. The Vitamin D questionnaire [ Time Frame: Day 0 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02636829


Locations
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France
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Principal Investigator: Eric Thouvenot, MD, PhD Centre Hospitalier Universitaire de Nîmes

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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT02636829     History of Changes
Other Study ID Numbers: LOCAL/2015/ET-01
2015-A01033-46 ( Other Identifier: RCB number )
First Posted: December 22, 2015    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Multiple Sclerosis
Arthritis
Sclerosis
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes
Autoimmune Diseases
Immune System Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Calcium, Dietary
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents