Multiple Sclerosis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREIndividual dietary consultations
Individual dietary consultations with a dietician will be held at inclusion, month 1 and month 3. Consults consist of a personal interview where the dietician delivers comprehensive information to the patient on how to optimize calcium intake and reduce the risk of fractures; the dietician questions the subject on his/her diet and reassesses the quality and quantity of calcium intake during the 3 days preceding the consultation through a survey calculation software based on data from CIQUAL.
PROCEDUREDietary advice sheet
At the beginning neurological consult, patients will be delivered a dietary advice sheet called Grio.
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
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 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Calcium intake in mg per day | Day 0 | Evaluation of calcium intake during a consultation with the dietician (CIQUAL data) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Paced Auditory Serial Addition Test | Day 0 | — |
| Hospital Anxiety and Depression Scale | Day 0 | — |
| EQ-5D questionnaire | Day 0 | EQ-5D™ is a standardised instrument for use as a measure of health outcome. (general health scale). |
| Mini Fatigue Impact Scale | Day 0 | — |
| Expanded Disability Status Scale (EDSS) | 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 | — |
| QALCIMUM questionnaire (mg/day) | Day 0 | — |
| Dietary classification | Day 0 | Patient diet classified as: normal; vegetarian, vegetalian; Seignalet; Kousmine; other. |
Countries
France
Outcome results
None listed