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NCT Number: NCT02636829

Validation of Self-administered Questionnaire for Assessing Calcium Intake in Patients With Multiple Sclerosis 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.

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Key information

Conditions

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

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QALCIMUM questionnaire

Other

All patients will fill out the QALCIMUM questionnaire.

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: QALCIMUM

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Dec 22, 2015
Registry last updated
Sep 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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