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Body Composition in Systemic Amyloidosis

NCT02111538 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 127

Last updated 2025-05-01

No results posted yet for this study

Summary

Malnutrition is a prominent clinical feature of patients affected by systemic immunoglobulin light-chain amyloidosis (AL), with a prevalence ranging between 25-50%. Although the prognosis predominantly depend on the presence and severity of cardiac involvement, it was shown that malnutrition is an independent predictor of survival and quality of life. However, the assessment of nutritional status by common indices based on anthropometry is not always feasible and accurate due to reduced performance status and/or the presence of fluid imbalances (for example edema and ascites). Several recent studies have demonstrated the prognostic value of the phase angle. Moreover, the value is supported by its applicability to patients who are bedridden or present alterations in the state of hydration.

Conditions

  • Amyloidosis

Interventions

OTHER

Dietary advice

Standard dietary advice are provided to all patients at baseline and during the follow-up to all requiring or asking for

Sponsors & Collaborators

  • Akern Srl

    collaborator INDUSTRY

  • Fondazione IRCCS Policlinico San Matteo di Pavia

    lead OTHER

Principal Investigators

  • Riccardo Caccialanza, MD · Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo

  • Giampaolo Merlini, MD, PhD · Amyloidosis Research and Treatment Center, Fondazione IRCCS Policlinico San Matteo

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2019-04-30
Completion
2019-04-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02111538 on ClinicalTrials.gov