Study on the safety and nutritional status improvement of L-arginine hydrochloride intervention for ALS

JRCT ID: jRCTs061230001

Registered date:11/04/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Amyotrophic lateral sclerosis
• Date of first enrollment: 25/05/2023
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Taking L-arginine hydrochloride for 3 months

Outcome(s)

• Primary Outcome: Safety

Secondary Outcome

Nutritional status, height, weight, BMI, Mini Nutritional Assessment, Subjective Global Assessment, somatic fat volume
The revised ALS functional rating scale
Presence or absence of ALS-related events (gastrostomy, pneumonia, non-invasive positive pressure ventilation, ventilator placement, tracheostomy, death)
Analysis by compliance rate of internal medication

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Diagnosed as ALS by Gold Coast criteria
Patients visiting or admitted in our hospital, and can be followed up more than 3 months

Exclude criteria

Arginase deficiency
Lysineuric protein intolerance whose absorption inhibition of L-arginine hydrochloride is great in degree
Taking Argi-U
Using ventilator
Scheduled for surgery at the time of registration

Related Information

• Primary Sponsor: Horofumi Maruyama
• Source(s) of Monetary Support: Ajinomoto Co.,the Japan Society for the Promotion of Science KAKENHI (grant numbers 23K16642)