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Completed

NCT Number: NCT02664623

Personalized Nutrition Advice for Optimizing Dietary Calcium Intake in MS Patients

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.

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Key information

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH d'Alès, Alès, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Dietary advice sheet

Procedure

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study 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

Acronym: CalciCoach

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jan 27, 2016
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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