Personalized Nutrition Advice for Optimizing Dietary Calcium Intake in
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
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Individual dietary consultations
- Dietary advice sheet
What it measured
Main measures
Calcium intake in mg per day
Day 0
Calcium intake in mg per day
Month 6
Other measures (15)
QALCIMUM questionnaire (mg/day)
Day 0
QALCIMUM questionnaire (mg/day)
Month 6
Expanded Disability Status Scale (EDSS)
Day 0
Disability progressionExpanded Disability Status Scale (EDSS)
Month 6
Disability progressionPaced Auditory Serial Addition Test
Day 0
Paced Auditory Serial Addition Test
Month 6
Hospital Anxiety and Depression Scale
Day 0
Mood and sleepHospital Anxiety and Depression Scale
Month 6
Mood and sleepEQ-5D questionnaire
Day 0
Quality of life (reported by participants)EQ-5D questionnaire
Month 6
Quality of life (reported by participants)
Who could take part
MS (type not specified) · 18 to 69
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
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History
Started
Jul 2016
Main results due
Jan 2020
Finished
Jan 2020