Nutritional Counseling in Systemic Immunoglobulin Light-chain Amyloidosis

February 6, 2014 updated by: Riccardo Caccialanza, IRCCS Policlinico S. Matteo

Nutritional Counseling in Systemic Immunoglobulin Light-chain (AL) Amyloidosis: a Prospective Randomized, Controlled Trial.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pavia, Italy, 27100
        • Fondazione Irccs Policlinico San Matteo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Other: 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
Other: General dietary advices
General dietary advices are provided. Follow-up evaluations take place during the visits scheduled by the Amyloidosis Center
Other: General dietary advices
General dietary advices are provided. Follow-up evaluations take place during the visits scheduled by the oncologists

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body weight
Time Frame: 12 months
Change in body weight at 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 12 months
Change in quality of life at 12 months
12 months
Overall survival
Time Frame: 12 months
Overall survival at the end of study
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Policlinico S. Matteo

Investigators

  • Principal Investigator: Riccardo Caccialanza, MD, Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo, Italy
  • Study Chair: Giampaolo Merlini, MD, Amyloidosis Research and Treatment Center, Biotechnology Research Laboratories, Department of Molecular Medicine, Fondazione IRCCS Policlinico San Matteo and University of Pavia, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

February 4, 2014

First Submitted That Met QC Criteria

February 4, 2014

First Posted (Estimate)

February 5, 2014

Study Record Updates

Last Update Posted (Estimate)

February 7, 2014

Last Update Submitted That Met QC Criteria

February 6, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PVSMATT01 - amyloid nutr

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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