Nutritional Counseling in Systemic Immunoglobulin Light-chain Amyloidosis

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Amyloidosis

Treatments: Other: Nutritional counseling; Other: General dietary advices

Study type: Interventional

Funder types: Other

Identifiers

NCT02055534

PVSMATT01 - amyloid nutr

Details and patient eligibility

About

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.

Enrollment: 144 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 2 patient groups

Nutritional counseling

Experimental group

Description:

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

Treatment:

Other: Nutritional counseling

General dietary advices

Other group

Description:

General dietary advices are provided. Follow-up evaluations take place during the visits scheduled by the Amyloidosis Center

Treatment:

Other: General dietary advices