Validation of Self-administered Questionnaire Specifically for Assessing Calcium Intake (QALCIMUM®) in Patients With Multiple Sclerosis (MS) or Chronic Inflammatory Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Calcium intake (mg/day)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Calcium intake (mg/day)
时间窗: Day 0
As determined by a consultation with a dietician.
The QALCIMUM questionnaire
时间窗: Day 0
次要结局
- Quality of Life questionnaire: MSIS29 (MS Impact Scale)(Day 0)
- QALCIMUM questionnaire administration time (minutes)(Day 0)
- The GRIO questionnaire(Day 0)
- The FRAX questionnaire(Day 0)
- The Vitamin D questionnaire(Day 0)
- Patient diet (qualitative)(Day 0)
- Quality of Life questionnaire: TLSQOL10(Day 0)
- Quality of Life questionnaire: TLS Coping(Day 0)