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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02636829
Acronym
QALCIMUM
Enrollment
100
Registered
2015-12-22
Start date
2016-03-31
Completion date
2016-08-31
Last updated
2016-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Rheumatoid Arthritis

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.

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

Interventions

OTHERQALCIMUM questionnaire

All patients will fill out the QALCIMUM questionnaire.

OTHERDetermination 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.

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Calcium intake (mg/day)Day 0As determined by a consultation with a dietician.
The QALCIMUM questionnaireDay 0

Secondary

MeasureTime frameDescription
The GRIO questionnaireDay 0GRIO = Osteoporosis Research and Information Group
The FRAX questionnaireDay 0FRAX = WHO Fracture RISK Assessment Tool
Quality of Life questionnaire: MSIS29 (MS Impact Scale)Day 0
Patient diet (qualitative)Day 0Patient diet classified as: normal; vegetarian, vegetalian; Seignalet; Kousmine; other.
Quality of Life questionnaire: TLS CopingDay 0
The Vitamin D questionnaireDay 0
Quality of Life questionnaire: TLSQOL10Day 0
QALCIMUM questionnaire administration time (minutes)Day 0

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026