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
2 other identifiers
interventional
182
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable multiple-sclerosis
Started Jul 2016
Longer than P75 for not_applicable multiple-sclerosis
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2016
CompletedFirst Posted
Study publicly available on registry
January 27, 2016
CompletedStudy Start
First participant enrolled
July 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 6, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 6, 2020
CompletedDecember 1, 2025
January 1, 2020
3.5 years
January 19, 2016
November 24, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (15)
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
- +10 more secondary outcomes
Study Arms (2)
Dietary advice sheet
EXPERIMENTALPatients 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
EXPERIMENTALIn 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
Interventions
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.
At the beginning neurological consult, patients will be delivered a dietary advice sheet called "Grio".
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- The patient is participating in another non-observational 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CH d'Alès
Alès, 30103, France
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029, France
Related Publications (1)
Fiorella S, Agherbi H, El Houjeiry E, Castelnovo G, Renard D, Privat P, Santamaria E, Vallayer V, Alonso S, Chevallier T, Bancal C, Laurent-Chabalier S, Thouvenot E. Personalized dietary advices provided by a dietitian increase calcium intake in outpatients with multiple sclerosis-Results from a randomized, controlled, single-blind trial. Front Nutr. 2023 Jan 17;9:919336. doi: 10.3389/fnut.2022.919336. eCollection 2022.
PMID: 36733470RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Thouvenot, MD, PhD
Centre Hospitalier Universitaire de Nîmes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2016
First Posted
January 27, 2016
Study Start
July 13, 2016
Primary Completion
January 6, 2020
Study Completion
January 6, 2020
Last Updated
December 1, 2025
Record last verified: 2020-01