Personalized Nutrition Advice for Optimizing Dietary Calcium Intake in MS Patients

Multiple Sclerosis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02664623
• Other study ID #: LOCAL/2015/ET-02
• Secondary ID: 2015-A01618-41
• Status: Completed
• Phase: N/A
• Start date: July 13, 2016
• Est. completion date: January 6, 2020

Study information

• Verified date: January 2020
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

*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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: January 6, 2020
• Est. primary completion date: January 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
France	CH d'Alès	Alès
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calcium intake in mg per day	Evaluation of calcium intake during a consultation with the dietician (CIQUAL data)	Day 0
Primary	Calcium intake in mg per day	Evaluation of calcium intake during a consultation with the dietician (CIQUAL data)	Month 6
Secondary	QALCIMUM questionnaire (mg/day)		Day 0
Secondary	QALCIMUM questionnaire (mg/day)		Month 6
Secondary	Expanded Disability Status Scale (EDSS)		Day 0
Secondary	Expanded Disability Status Scale (EDSS)		Month 6
Secondary	Paced Auditory Serial Addition Test		Day 0
Secondary	Paced Auditory Serial Addition Test		Month 6
Secondary	Hospital Anxiety and Depression Scale		Day 0
Secondary	Hospital Anxiety and Depression Scale		Month 6
Secondary	EQ-5D questionnaire	EQ-5D™ is a standardised instrument for use as a measure of health outcome. (general health scale).	Day 0
Secondary	EQ-5D questionnaire	EQ-5D™ is a standardised instrument for use as a measure of health outcome. (general health scale).	Month 6
Secondary	Mini Fatigue Impact Scale		Day 0
Secondary	Mini Fatigue Impact Scale		Month 6
Secondary	Dietary classification	Patient diet classified as: normal; vegetarian, vegetalian; Seignalet; Kousmine; other.	Day 0
Secondary	25-hydroxy-vitamin D (D2 + D3) levels (nmol/L)		Day 0
Secondary	25-hydroxy-vitamin D (D2 + D3) plasma levels (nmol/L)		Month 6