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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-A01618-41 | Other Identifier | ANSM |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary advice sheet | Experimental | Patients in this arm will receive a dietary advice sheet at the beginning of the study. Intervention: Dietary advice sheet |
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| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individual dietary consultations | Procedure | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| QALCIMUM questionnaire (mg/day) | Day 0 | |
| QALCIMUM questionnaire (mg/day) | Month 6 | |
| Expanded Disability Status Scale (EDSS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Thouvenot, MD, PhD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH d'Alès | Alès | 30103 | France | |||
| CHRU de Nîmes - Hôpital Universitaire Carémeau |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36733470 | Result | 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. |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| Dietary advice sheet | Procedure | At the beginning neurological consult, patients will be delivered a dietary advice sheet called "Grio". |
|
| 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 |
| Nîmes |
| 30029 |
| France |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |