Nutritional Counseling in Systemic Immunoglobulin Light-chain Amyloidosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2013-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Amyloidosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Nutritional counseling

Intervention Type OTHER

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 oncologists

General dietary advices

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

Group Type OTHER

General dietary advices

Intervention Type OTHER

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

Interventions

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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 oncologists

Intervention Type OTHER

General dietary advices

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Riccardo Caccialanza

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Riccardo Caccialanza, MD

Role: PRINCIPAL_INVESTIGATOR

Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo, Italy

Giampaolo Merlini, MD

Role: STUDY_CHAIR

Amyloidosis Research and Treatment Center, Biotechnology Research Laboratories, Department of Molecular Medicine, Fondazione IRCCS Policlinico San Matteo and University of Pavia, Italy