Effectiveness of Personalized Nutrition Advice Delivered Via Dietary Consultations for Optimizing Dietary Calcium Intake in Patients With Multiple Sclerosis (MS) and Monitored as Outpatients: a Randomized, Single-blind, Bicentric Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 182
- 试验地点
- 4
- 主要终点
- Calcium intake in mg per day
研究概览
简要总结
The main objective of this study is to measure effectiveness at 6 months of personalized dietary advice versus dietary counseling via delivery of a standard advice sheet for optimizing dietary calcium intake (assessed by a food survey based on CIQUAL* data) in MS patients with ambulatory monitoring.
*CIQUAL Data: Table of nutritional food composition available on the ANSES (National Agency for Sanitary Security of Food, Environment and Labour) website, published by the Observatory of the Nutritional Quality of Foods. This table includes 1,500 sheets of 58 nutritional components. The data is integrated into the software for calculating ingesta (DATAMEAL) at the Nîmes University Hospital.
详细描述
The secondary objectives of this study is to compare the two groups in order to:
A- correlate the impact of the recommendations by sheet or consult with disability, cognitive status, fatigue, depression, quality of life of patients with MS.
B- assess the prevalence of diet changes as an alternative therapy for lactose intolerance in the population and to correlate these changes with dietary calcium intake at baseline (assessed by a food survey based on CIQUAL* data).
C- assess calcium intake of the patients included via the self-administered frequency questionnaire QALCIMUM® on day 0 and 6 months and to compare them with data obtained by the food survey based on data from CIQUAL.
D- correlate calcium intake of the patients with vitamin D levels at inclusion and establish a biological collection of blood samples from the population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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 a confirmed diagnosis of remitting multiple sclerosis
- •Ambulatory patient (EDSS score < 6.5) who has never had a dietary consultation concerning the optimization of calcium intake
排除标准
- •The patient is participating in another non-observational study
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection, under tutorship or curatorship
- •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
- •Vitamin D deficiency linked to currently active digestive or general diseases
- •Moderate or severe renal impairment (creatinine clearance <60ml / min)
- •Situations accompanied by increased vulnerability to hypercalcemia, eg arrhythmia or known heart disease, treatment with digitalis, subjects with nephrolithiasis
结局指标
主要结局
Calcium intake in mg per day
时间窗: Month 6
Evaluation of calcium intake during a consultation with the dietician (CIQUAL data)
次要结局
- QALCIMUM questionnaire (mg/day)(Month 6)
- Paced Auditory Serial Addition Test(Month 6)
- Expanded Disability Status Scale (EDSS)(Month 6)
- Hospital Anxiety and Depression Scale(Month 6)
- EQ-5D questionnaire(Month 6)
- Mini Fatigue Impact Scale(Month 6)
- Dietary classification(Day 0)
- 25-hydroxy-vitamin D (D2 + D3) levels (nmol/L)(Day 0)
- 25-hydroxy-vitamin D (D2 + D3) plasma levels (nmol/L)(Month 6)