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OpenTrials
Completed

NCT Number: NCT02055534

Nutritional Counseling in Systemic Immunoglobulin Light-chain Amyloidosis

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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Key information

Conditions

Amyloidosis Metabolic Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nutritional counseling

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

Other

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

Primary outcomes

  1. Body weight

    Time frame: 12 months

    Change in body weight at 12 months

Secondary outcomes

  1. Quality of life

    Time frame: 12 months

    Change in quality of life at 12 months

  2. Overall survival

    Time frame: 12 months

    Overall survival at the end of study

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Feb 5, 2014
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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