NCT02055534CompletedNot Applicable
Nutritional Counseling in Systemic Immunoglobulin Light-chain (AL) Amyloidosis: a Prospective Randomized, Controlled Trial.
Fondazione IRCCS Policlinico San Matteo di Pavia2 sites in 1 country144 target enrollmentStarted: July 1, 2007Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 144
- Locations
- 2
- Primary Endpoint
- Body weight
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Body weight
Time Frame: 12 months
Change in body weight at 12 months
Secondary Outcomes
- Quality of life(12 months)
- Overall survival(12 months)
Investigators
Riccardo Caccialanza
Principal Investigator
Fondazione IRCCS Policlinico San Matteo di Pavia
Study Sites (2)
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