NCT02636829

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

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

Conditions

• Multiple Sclerosis
• Rheumatoid Arthritis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2015-12-22
• Last updated: 2016-09-15

Locations

1 site across 1 country: France