Multiple SclerosisQALCIMUMNCT02636829
Validation of Self-administered Questionnaire for Assessing Calcium Intake in Patients With Multiple Sclerosis or Chronic Inflammatory Arthritis
A study testing QALCIMUM questionnaire and Determination of calcium intake by a dietician interview in people with Multiple Sclerosis and Rheumatoid Arthritis, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Multiple Sclerosis, Rheumatoid Arthritis
- What is being tested?
- QALCIMUM questionnaire and Determination of calcium intake by a dietician interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2016to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Self-administered Questionnaire Specifically for Assessing Calcium Intake (QALCIMUM®) in Patients With Multiple Sclerosis (MS) or Chronic Inflammatory Arthritis
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.
Read the detailed description
The secondary objectives of this study are:
- To estimate the average calcium intake and variability in a population of MS patients and the proportion of patients at risk for osteoporosis.
- To estimate the average calcium intake and variability in a population of CIA patients and the proportion of patients at risk for osteoporosis.
- To describe the dietary changes observed in MS or CIA patients .
- To estimate the administration time of the QALCIMUM® self-questionnaire.
- 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
- To assess the quality of life of patients with MS or CIA
- To evaluate endogenous mean vitamin D production in a population of patients with MS or CIA
- Conditions
- Multiple Sclerosis, Rheumatoid Arthritis
- Being tested
- QALCIMUM questionnaire, Determination of calcium intake by a dietician interview
- Medical subject headings
- Multiple Sclerosis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QALCIMUM questionnaireOther
All patients will fill out the QALCIMUM questionnaire.
Determination of calcium intake by a dietician interviewOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: QALCIMUM questionnaire; Other: Determination of calcium intake by a dietician interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calcium intake (mg/day)
As determined by a consultation with a dietician.
Measured: Day 0
The QALCIMUM questionnaire
Measured: Day 0
Secondary outcomes (8)
Patient diet (qualitative)
Patient diet classified as: normal; vegetarian, vegetalian; Seignalet; Kousmine; other.
Measured: Day 0
QALCIMUM questionnaire administration time (minutes)
Measured: Day 0
The GRIO questionnaire
GRIO = Osteoporosis Research and Information Group
Measured: Day 0
The FRAX questionnaire
FRAX = WHO Fracture RISK Assessment Tool
Measured: Day 0
Quality of Life questionnaire: MSIS29 (MS Impact Scale)
Measured: Day 0
Quality of Life questionnaire: TLSQOL10
Measured: Day 0
Quality of Life questionnaire: TLS Coping
Measured: Day 0
The Vitamin D questionnaire
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startMar 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Thouvenot, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636829
- Sponsor's protocol ID
- LOCAL/2015/ET-01
- Other IDs
- 2015-A01033-46
- Acronym
- QALCIMUM
- Status last verified
- Sep 2016
- First submitted
- 17 Nov 2015
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Self-administered Questionnaire Specifically for Assessing Calcium Intake (QALCIMUM®) in Patients With Multiple Sclerosis (MS) or Chronic Inflammatory Arthritis
- ClinicalTrials.gov ID
- NCT02636829
- Acronym / sponsor ID
- QALCIMUM / LOCAL/2015/ET-01
- Conditions
- Multiple Sclerosis, Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 22 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To estimate the average calcium intake and variability in a population of MS patients and the proportion of patients at risk for osteoporosis.
- To estimate the average calcium intake and variability in a population of CIA patients and the proportion of patients at risk for osteoporosis.
- To describe the dietary changes observed in MS or CIA patients .
- To estimate the administration time of the QALCIMUM® self-questionnaire.
- 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
- To assess the quality of life of patients with MS or CIA
- To evaluate endogenous mean vitamin D production in a population of patients with MS or CIA
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple Sclerosis patients | Experimental | Other: QALCIMUM questionnaire, Other: Determination of calcium intake by a dietician interviewPatients (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 |
| Rheumatoid Arthritis patients | Experimental | Other: QALCIMUM questionnaire, Other: Determination of calcium intake by a dietician interviewPatients (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 |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QALCIMUM questionnaireAll patients will fill out the QALCIMUM questionnaire. | Other | Multiple Sclerosis patients, Rheumatoid Arthritis patients |
| Determination of calcium intake by a dietician interviewAll 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. | Other | Multiple Sclerosis patients, Rheumatoid Arthritis patients |
Primary outcome
Calcium intake (mg/day)
Time frame: Day 0
As determined by a consultation with a dietician.
The QALCIMUM questionnaire
Time frame: Day 0
8 secondary outcomes
Patient diet (qualitative)
Time frame: Day 0
QALCIMUM questionnaire administration time (minutes)
Time frame: Day 0
The GRIO questionnaire
Time frame: Day 0
The FRAX questionnaire
Time frame: Day 0
Quality of Life questionnaire: MSIS29 (MS Impact Scale)
Time frame: Day 0
Quality of Life questionnaire: TLSQOL10
Time frame: Day 0
Quality of Life questionnaire: TLS Coping
Time frame: Day 0
The Vitamin D questionnaire
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Thouvenot, MD, PhD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QALCIMUM questionnaire and Determination of calcium intake by a dietician interview in people with Multiple Sclerosis and Rheumatoid Arthritis, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calcium intake (mg/day) (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2016.