search
Back to results

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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Individual dietary consultations
Dietary advice sheet
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CH d'Alès
  • CHRU de Nîmes - Hôpital Universitaire Carémeau

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dietary advice sheet

Dietary advice sheet + consults with dietician

Arm Description

Patients in this arm will receive a dietary advice sheet at the beginning of the study. Intervention: Dietary advice sheet

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

Outcomes

Primary Outcome Measures

Calcium intake in mg per day
Evaluation of calcium intake during a consultation with the dietician (CIQUAL data)
Calcium intake in mg per day
Evaluation of calcium intake during a consultation with the dietician (CIQUAL data)

Secondary Outcome Measures

QALCIMUM questionnaire (mg/day)
QALCIMUM questionnaire (mg/day)
Expanded Disability Status Scale (EDSS)
Expanded Disability Status Scale (EDSS)
Paced Auditory Serial Addition Test
Paced Auditory Serial Addition Test
Hospital Anxiety and Depression Scale
Hospital Anxiety and Depression Scale
EQ-5D questionnaire
EQ-5D™ is a standardised instrument for use as a measure of health outcome. (general health scale).
EQ-5D questionnaire
EQ-5D™ is a standardised instrument for use as a measure of health outcome. (general health scale).
Mini Fatigue Impact Scale
Mini Fatigue Impact Scale
Dietary classification
Patient diet classified as: normal; vegetarian, vegetalian; Seignalet; Kousmine; other.
25-hydroxy-vitamin D (D2 + D3) levels (nmol/L)
25-hydroxy-vitamin D (D2 + D3) plasma levels (nmol/L)

Full Information

First Posted
January 19, 2016
Last Updated
January 23, 2020
Sponsor
Centre Hospitalier Universitaire de Nīmes
search

1. Study Identification

Unique Protocol Identification Number
NCT02664623
Brief Title
Personalized Nutrition Advice for Optimizing Dietary Calcium Intake in MS Patients
Acronym
CalciCoach
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
July 13, 2016 (Actual)
Primary Completion Date
January 6, 2020 (Actual)
Study Completion Date
January 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dietary advice sheet
Arm Type
Experimental
Arm Description
Patients in this arm will receive a dietary advice sheet at the beginning of the study. Intervention: Dietary advice sheet
Arm Title
Dietary advice sheet + consults with dietician
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Individual dietary consultations
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Dietary advice sheet
Intervention Description
At the beginning neurological consult, patients will be delivered a dietary advice sheet called "Grio".
Primary Outcome Measure Information:
Title
Calcium intake in mg per day
Description
Evaluation of calcium intake during a consultation with the dietician (CIQUAL data)
Time Frame
Day 0
Title
Calcium intake in mg per day
Description
Evaluation of calcium intake during a consultation with the dietician (CIQUAL data)
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
QALCIMUM questionnaire (mg/day)
Time Frame
Day 0
Title
QALCIMUM questionnaire (mg/day)
Time Frame
Month 6
Title
Expanded Disability Status Scale (EDSS)
Time Frame
Day 0
Title
Expanded Disability Status Scale (EDSS)
Time Frame
Month 6
Title
Paced Auditory Serial Addition Test
Time Frame
Day 0
Title
Paced Auditory Serial Addition Test
Time Frame
Month 6
Title
Hospital Anxiety and Depression Scale
Time Frame
Day 0
Title
Hospital Anxiety and Depression Scale
Time Frame
Month 6
Title
EQ-5D questionnaire
Description
EQ-5D™ is a standardised instrument for use as a measure of health outcome. (general health scale).
Time Frame
Day 0
Title
EQ-5D questionnaire
Description
EQ-5D™ is a standardised instrument for use as a measure of health outcome. (general health scale).
Time Frame
Month 6
Title
Mini Fatigue Impact Scale
Time Frame
Day 0
Title
Mini Fatigue Impact Scale
Time Frame
Month 6
Title
Dietary classification
Description
Patient diet classified as: normal; vegetarian, vegetalian; Seignalet; Kousmine; other.
Time Frame
Day 0
Title
25-hydroxy-vitamin D (D2 + D3) levels (nmol/L)
Time Frame
Day 0
Title
25-hydroxy-vitamin D (D2 + D3) plasma levels (nmol/L)
Time Frame
Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Thouvenot, MD, PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH d'Alès
City
Alès
ZIP/Postal Code
30103
Country
France
Facility Name
CHRU de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes Cedex 09
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

Learn more about this trial

Personalized Nutrition Advice for Optimizing Dietary Calcium Intake in MS Patients

We'll reach out to this number within 24 hrs