Personalized Nutrition Advice for Optimizing Dietary Calcium Intake in MS Patients

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Procedure: Dietary advice sheet; Procedure: Individual dietary consultations

• Registration Number: NCT02664623
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Study Timeline

• Study First Submitted: 2016-01-19
• Study First Submitted QC: 2016-01-22
• Study First Posted: 2016-01-27
• Study Start: 2016-07-13
• Status Verified: 2020-01
• Primary Completion: 2020-01-06
• Study Completion: 2020-01-06
• Last Update Submitted: 2020-01-23
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dietary advice sheet	Dietary advice sheet	Patients in this arm will receive a dietary advice sheet at the beginning of the study. Intervention: Dietary advice sheet
Dietary advice sheet + consults with dietician	Individual dietary consultations	In addition to receiving a dietary advice sheet at the beginning of the study, patients randomized to this arm will have individual consultations with a dietician at inclusion, month 1 and month 3. Intervention: Dietary advice sheet Intervention: Individual dietary consultations
Dietary advice sheet + consults with dietician	Dietary advice sheet	In addition to receiving a dietary advice sheet at the beginning of the study, patients randomized to this arm will have individual consultations with a dietician at inclusion, month 1 and month 3. Intervention: Dietary advice sheet Intervention: Individual dietary consultations

Primary Outcome Measures

Name	Time	Method
Calcium intake in mg per day	Month 6	Evaluation of calcium intake during a consultation with the dietician (CIQUAL data)

Secondary Outcome Measures

Name	Time	Method
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	EQ-5D™ is a standardised instrument for use as a measure of health outcome. (general health scale).
Mini Fatigue Impact Scale	Month 6
Dietary classification	Day 0	Patient diet classified as: normal; vegetarian, vegetalian; Seignalet; Kousmine; other.
25-hydroxy-vitamin D (D2 + D3) levels (nmol/L)	Day 0
25-hydroxy-vitamin D (D2 + D3) plasma levels (nmol/L)	Month 6

Trial Locations

Locations (2)

CH d'Alès; 🇫🇷 Alès, France

CHRU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France