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

Rheumatoid Arthritis Clinical Trial

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

Status Completed

Clinical 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 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.

Clinical Trial 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 ;

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Multiple Sclerosis
• Rheumatoid Arthritis
• Sclerosis

• NCT number: NCT02636829
• Study type: Interventional
• Source: Centre Hospitalier Universitaire de Nimes
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Completion date: August 2016