Nutritional Counseling in Systemic Immunoglobulin Light-chain Amyloidosis

Not Applicable

Completed

• Conditions: Amyloidosis
• Interventions: Other: Nutritional counseling; Other: General dietary advices

• Registration Number: NCT02055534
• Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

Brief Summary

Poor nutritional status is common in patients with systemic immunoglobulin light-chain (AL) amyloidosis and has been associated with mortality and impaired quality of life (QoL). We investigated whether nutritional counseling is beneficial to the maintenance of nutritional status and QoL in AL outpatients.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-02
• Study First Submitted: 2014-02-04
• Study First Submitted QC: 2014-02-04
• Study First Posted: 2014-02-05
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

• Treatment naïve patients with with systemic immunoglobulin light-chain amyloidosis
• Availability to planned measurements and to written informed consent

Exclusion Criteria

• Age < 18 years
• Indication to organ transplantation
• Indication to autologous stem cell transplantation
• Need to start or ongoing dialysis
• Ascites or massive edema
• Need to start or ongoing artificial nutrition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutritional counseling	Nutritional counseling	Nutritional counseling consists in: personalized dietary prescription associated with regular (every 3 weeks) dietetic advise by a registered dietician. Follow-up evaluations take place also during the visits scheduled by the Amyloidosis Center
General dietary advices	General dietary advices	General dietary advices are provided. Follow-up evaluations take place during the visits scheduled by the Amyloidosis Center

Primary Outcome Measures

Name	Time	Method
Body weight	12 months	Change in body weight at 12 months

Secondary Outcome Measures

Name	Time	Method
Quality of life	12 months	Change in quality of life at 12 months
Overall survival	12 months	Overall survival at the end of study

Trial Locations

Locations (1)

Fondazione IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy