Oral Nutritional Supplementation in Amyotrophic Lateral Sclerosis (ALS) Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 30 August 2021
• Main ID: NCT02152449
• Date of registration: 28/05/2014
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Limoges
• Public title: Oral Nutritional Supplementation in Amyotrophic Lateral Sclerosis (ALS) Patients NUTRALS
• Scientific title: Impact on Functional Status of Early Oral Nutritional Supplementation (ONS) in Amyotrophic Lateral Sclerosis (ALS) Patients
• Date of first enrolment: July 2014
• Target sample size: 229
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02152449
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Philippe COURATIER, MD
• Affiliation: CHU Limoges

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients =18 years of age, diagnosed with ALS (<2 months before inclusion) according
to Airlie House criteria : definite, probable, or probable laboratory supported;

- Time between first symptoms and diagnosis less than 18 months

- Sporadic or familial cases

- Patient agreement to be followed in a given ALS centre during the duration of the
study

- Patients with a loss of at least 1 point in 3 items of the ALSFRS-R rating scale or
with a loss of at least 2 points in 2 items of the ALSFRS-R rating scale

- Patients who signed the informed consent form

Exclusion Criteria:

- Associated dementia or inability to understand the requirements of the protocol.

- No helper

- ONS already begun

- Artificial nutrition: enteral or parenteral nutrition

- Known hypersensitivity to components of ONS

- Absence of treatment with Riluzole (RILUTEK®)

- Patient under guardianship or curatorship

- Participation in another research protocol.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis (ALS)

Intervention(s)

Dietary Supplement: Oral nutritional supplementation

Primary Outcome(s)

Change in the ALSFRS-R slope between T0 and T0+6 months [Time Frame: Month 6]

Secondary Outcome(s)

Combined assessment of Function and Survival (CAFS) [Time Frame: Mont 3 and month 6]

Body Mass Index and of Fat Mass. [Time Frame: Day 1, month 3, months 6:]

Secondary ID(s)

I12025

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Laboratoires NUTRICIA