Clinical trial NCT02664623: Personalized Nutrition Advice for Optimizing Dietary Calcium Intake in MS Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2016-01-27
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Calcium intake in mg per day
timeFrame: Day 0
measure: Calcium intake in mg per day
timeFrame: Month 6
Secondary outcomes:
measure: QALCIMUM questionnaire (mg/day)
timeFrame: Day 0
measure: QALCIMUM questionnaire (mg/day)
timeFrame: Month 6
measure: Expanded Disability Status Scale (EDSS)
timeFrame: Day 0
measure: Expanded Disability Status Scale (EDSS)
timeFrame: Month 6
measure: Paced Auditory Serial Addition Test
timeFrame: Day 0
measure: Paced Auditory Serial Addition Test
timeFrame: Month 6
measure: Hospital Anxiety and Depression Scale
timeFrame: Day 0
measure: Hospital Anxiety and Depression Scale
timeFrame: Month 6
measure: EQ-5D questionnaire
timeFrame: Day 0
measure: EQ-5D questionnaire
timeFrame: Month 6
measure: Mini Fatigue Impact Scale
timeFrame: Day 0
measure: Mini Fatigue Impact Scale
timeFrame: Month 6
measure: Dietary classification
timeFrame: Day 0
measure: 25-hydroxy-vitamin D (D2 + D3) levels (nmol/L)
timeFrame: Day 0
measure: 25-hydroxy-vitamin D (D2 + D3) plasma levels (nmol/L)
timeFrame: Month 6
Other outcomes:
Locations:
city: Alès
country: France
facility: CH d'Alès
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Eric Thouvenot, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: