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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02664623
Recruitment Status : Completed
First Posted : January 27, 2016
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Procedure: Individual dietary consultations Procedure: Dietary advice sheet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
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
Actual Study Start Date : July 13, 2016
Actual Primary Completion Date : January 6, 2020
Actual Study Completion Date : January 6, 2020

Resource links provided by the National Library of Medicine


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: 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.

Procedure: Dietary advice sheet
At the beginning neurological consult, patients will be delivered a dietary advice sheet called "Grio".




Primary Outcome Measures :
  1. Calcium intake in mg per day [ Time Frame: Day 0 ]
    Evaluation of calcium intake during a consultation with the dietician (CIQUAL data)

  2. Calcium intake in mg per day [ Time Frame: Month 6 ]
    Evaluation of calcium intake during a consultation with the dietician (CIQUAL data)


Secondary Outcome Measures :
  1. QALCIMUM questionnaire (mg/day) [ Time Frame: Day 0 ]
  2. QALCIMUM questionnaire (mg/day) [ Time Frame: Month 6 ]
  3. Expanded Disability Status Scale (EDSS) [ Time Frame: Day 0 ]
  4. Expanded Disability Status Scale (EDSS) [ Time Frame: Month 6 ]
  5. Paced Auditory Serial Addition Test [ Time Frame: Day 0 ]
  6. Paced Auditory Serial Addition Test [ Time Frame: Month 6 ]
  7. Hospital Anxiety and Depression Scale [ Time Frame: Day 0 ]
  8. Hospital Anxiety and Depression Scale [ Time Frame: Month 6 ]
  9. EQ-5D questionnaire [ Time Frame: Day 0 ]
    EQ-5D™ is a standardised instrument for use as a measure of health outcome. (general health scale).

  10. EQ-5D questionnaire [ Time Frame: Month 6 ]
    EQ-5D™ is a standardised instrument for use as a measure of health outcome. (general health scale).

  11. Mini Fatigue Impact Scale [ Time Frame: Day 0 ]
  12. Mini Fatigue Impact Scale [ Time Frame: Month 6 ]
  13. Dietary classification [ Time Frame: Day 0 ]
    Patient diet classified as: normal; vegetarian, vegetalian; Seignalet; Kousmine; other.

  14. 25-hydroxy-vitamin D (D2 + D3) levels (nmol/L) [ Time Frame: Day 0 ]
  15. 25-hydroxy-vitamin D (D2 + D3) plasma levels (nmol/L) [ Time Frame: Month 6 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02664623


Locations
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France
CH d'Alès
Alès, France, 30103
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Principal Investigator: Eric Thouvenot, MD, PhD Centre Hospitalier Universitaire de Nîmes
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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT02664623    
Other Study ID Numbers: LOCAL/2015/ET-02
2015-A01618-41 ( Other Identifier: RCB number )
First Posted: January 27, 2016    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases