Personalized Nutrition Advice for Optimizing Dietary Calcium Intake in MS Patients (CalciCoach)

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Procedure: Dietary advice sheet; Procedure: Individual dietary consultations

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 Type: Interventional
• Enrollment (Actual): 182
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Alès, France, 30103
    • CH d'Alès
  • Nîmes Cedex 09, France, 30029
    • CHRU de Nîmes - Hôpital Universitaire Carémeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dietary advice sheet; Patients in this arm will receive a dietary advice sheet at the beginning of the study. Intervention: Dietary advice sheet	Procedure: Dietary advice sheet; At the beginning neurological consult, patients will be delivered a dietary advice sheet called "Grio".
Experimental: Dietary advice sheet + consults with dietician; 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	Procedure: Dietary advice sheet; At the beginning neurological consult, patients will be delivered a dietary advice sheet called "Grio".; Procedure: Individual 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calcium intake in mg per day	Evaluation of calcium intake during a consultation with the dietician (CIQUAL data)	Day 0
Calcium intake in mg per day	Evaluation of calcium intake during a consultation with the dietician (CIQUAL data)	Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QALCIMUM questionnaire (mg/day)		Day 0
QALCIMUM questionnaire (mg/day)		Month 6
Expanded Disability Status Scale (EDSS)		Day 0
Expanded Disability Status Scale (EDSS)		Month 6
Paced Auditory Serial Addition Test		Day 0
Paced Auditory Serial Addition Test		Month 6
Hospital Anxiety and Depression Scale		Day 0
Hospital Anxiety and Depression Scale		Month 6
EQ-5D questionnaire	EQ-5D™ is a standardised instrument for use as a measure of health outcome. (general health scale).	Day 0
EQ-5D questionnaire	EQ-5D™ is a standardised instrument for use as a measure of health outcome. (general health scale).	Month 6
Mini Fatigue Impact Scale		Day 0
Mini Fatigue Impact Scale		Month 6
Dietary classification	Patient diet classified as: normal; vegetarian, vegetalian; Seignalet; Kousmine; other.	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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2016
• Primary Completion (Actual): January 6, 2020
• Study Completion (Actual): January 6, 2020

Study Registration Dates

• First Submitted: January 19, 2016
• First Submitted That Met QC Criteria: January 22, 2016
• First Posted (Estimate): January 27, 2016

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 23, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: LOCAL/2015/ET-02; 2015-A01618-41 (Other Identifier: RCB number)