Multiple SclerosisCalciCoachNCT02664623
Personalized Nutrition Advice for Optimizing Dietary Calcium Intake in MS Patients
A study testing Individual dietary consultations and Dietary advice sheet in people with Multiple Sclerosis, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Individual dietary consultations and Dietary advice sheet
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 2 sitesFrance
- Study dates
- 13 Jul 2016to 6 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
CH d'Alès
Alès, 30103
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
About this study
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
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Individual dietary consultations, Dietary advice sheet
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual dietary consultationsProcedure or surgery
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.
Dietary advice sheetProcedure or surgery
At the beginning neurological consult, patients will be delivered a dietary advice sheet called "Grio".
| Study group | Role | What they receive |
|---|---|---|
| Dietary advice sheet | Experimental | Patients in this arm will receive a dietary advice sheet at the beginning of the study.
Intervention: Dietary advice sheet Receives: Procedure: Dietary advice sheet |
| Dietary advice sheet + consults with dietician | Experimental | 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 Receives: Procedure: Individual dietary consultations; Procedure: Dietary advice sheet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calcium intake in mg per day
Evaluation of calcium intake during a consultation with the dietician (CIQUAL data)
Measured: Day 0
Calcium intake in mg per day
Evaluation of calcium intake during a consultation with the dietician (CIQUAL data)
Measured: Month 6
Secondary outcomes (15)
QALCIMUM questionnaire (mg/day)
Measured: Day 0
QALCIMUM questionnaire (mg/day)
Measured: Month 6
Expanded Disability Status Scale (EDSS)
Measured: Day 0
Expanded Disability Status Scale (EDSS)
Measured: Month 6
Paced Auditory Serial Addition Test
Measured: Day 0
Paced Auditory Serial Addition Test
Measured: Month 6
Hospital Anxiety and Depression Scale
Measured: Day 0
Hospital Anxiety and Depression Scale
Measured: Month 6
EQ-5D questionnaire
EQ-5D™ is a standardised instrument for use as a measure of health outcome. (general health scale).
Measured: Day 0
EQ-5D questionnaire
EQ-5D™ is a standardised instrument for use as a measure of health outcome. (general health scale).
Measured: Month 6
Mini Fatigue Impact Scale
Measured: Day 0
Mini Fatigue Impact Scale
Measured: Month 6
Dietary classification
Patient diet classified as: normal; vegetarian, vegetalian; Seignalet; Kousmine; other.
Measured: Day 0
25-hydroxy-vitamin D (D2 + D3) levels (nmol/L)
Measured: Day 0
25-hydroxy-vitamin D (D2 + D3) plasma levels (nmol/L)
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study start13 Jul 2016
- Primary completion6 Jan 2020
- Study completion6 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Thouvenot, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02664623
- Sponsor's protocol ID
- LOCAL/2015/ET-02
- Other IDs
- 2015-A01618-41
- Acronym
- CalciCoach
- Status last verified
- Jan 2020
- First submitted
- 19 Jan 2016
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 36733470
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02664623
- Acronym / sponsor ID
- CalciCoach / LOCAL/2015/ET-02
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 13 Jul 2016 (actual)
- Primary completion
- 6 Jan 2020 (actual)
- Study completion
- 6 Jan 2020 (actual)
- First posted
- 27 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary advice sheet | Experimental | Procedure: Dietary advice sheetPatients 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 | Experimental | Procedure: Individual dietary consultations, Procedure: Dietary advice sheetIn 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 |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individual dietary consultationsIndividual 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. | Procedure or surgery | Dietary advice sheet + consults with dietician |
| Dietary advice sheetAt the beginning neurological consult, patients will be delivered a dietary advice sheet called "Grio". | Procedure or surgery | Dietary advice sheet, Dietary advice sheet + consults with dietician |
Primary outcome
Calcium intake in mg per day
Time frame: Day 0
Evaluation of calcium intake during a consultation with the dietician (CIQUAL data)
Calcium intake in mg per day
Time frame: Month 6
Evaluation of calcium intake during a consultation with the dietician (CIQUAL data)
15 secondary outcomes
QALCIMUM questionnaire (mg/day)
Time frame: Day 0
QALCIMUM questionnaire (mg/day)
Time frame: Month 6
Expanded Disability Status Scale (EDSS)
Time frame: Day 0
Expanded Disability Status Scale (EDSS)
Time frame: Month 6
Paced Auditory Serial Addition Test
Time frame: Day 0
Paced Auditory Serial Addition Test
Time frame: Month 6
Hospital Anxiety and Depression Scale
Time frame: Day 0
Hospital Anxiety and Depression Scale
Time frame: Month 6
EQ-5D questionnaire
Time frame: Day 0
EQ-5D questionnaire
Time frame: Month 6
Mini Fatigue Impact Scale
Time frame: Day 0
Mini Fatigue Impact Scale
Time frame: Month 6
Dietary classification
Time frame: Day 0
25-hydroxy-vitamin D (D2 + D3) levels (nmol/L)
Time frame: Day 0
25-hydroxy-vitamin D (D2 + D3) plasma levels (nmol/L)
Time frame: Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Results publication: PubMed 36733470Fiorella 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Thouvenot, MD, PhD principal investigator
Centre Hospitalier Universitaire de Nīmes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual dietary consultations and Dietary advice sheet in people with Multiple Sclerosis, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calcium intake in mg per day (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02664623, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.