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Dietary Reporting In The Amyloidoses

DRITA Pilot Trial: Dietary Reporting in the Amyloidoses

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05738005
Acronym
DRITA
Enrollment
40
Registered
2023-02-21
Start date
2023-03-02
Completion date
2028-11-21
Last updated
2026-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyloidosis

Brief summary

The goal of this clinical trial is to learn about malnutrition and weight loss in patients with Amyloidosis. The main question it aims to answer is: Is it feasible to use a low-cost nutrition-based application (apps) for use on a smartphone to obtain detailed information on caloric intake in Amyloidosis patients Participants will be asked to: * Download the MyFitnessPal application on their smartphone and view an online tutorial * After a week of practice, from weeks 2-9, participants will enter daily dietary intake as well as daily herbal/alternative supplement intake into the MyFitnessPal application on their smartphone. * complete a questionnaire prior to starting the application, after week 2 and at week 10 after starting the application

Interventions

OTHERTracking Dietary/Supplement Intake on MyFitnessPal smartphone application (app)

Amyloidosis patients will use MyFitnessPal application to track dietary intake and use of herbal/alternative supplements in from week 2-9. Patient's usage of the application and questionnaires completed by the patient at the start, Week 2 and Week 10 will determine feasibility.

Sponsors

Barbara Ann Karmanos Cancer Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 18 years of age or older * Diagnosed with any type of amyloidosis * Speak, read and write in English * Willing to use the MyFitnessPal app on their own smartphone

Exclusion criteria

* a planned autologous stem cell transplant or a solid organ transplant in the 12 weeks after enrollment * cognitive or perceptual disturbances

Design outcomes

Primary

MeasureTime frameDescription
Adherence Rate56 daysThe adherence is defined by the status (yes vs. no) of data recording per day; The adherence rate will be calculated by the ratio of the number of days of adherence to the total number of days of trial (i.e., 56 days); The status of data recording per day will be considered 'yes' if the participant completes a daily survey.

Secondary

MeasureTime frameDescription
Subsequent adherence rate63 days (= 56 days + Week 10)The subsequent adherence is the status of data recording per day during the third phase (Week 10) of trial participation (i.e., 7 days); The subsequent adherence rate will be calculated by the ratio of the number of days of adherence during the third phase (Week 10) of trial participation (i.e., 7 days); The status of data recording per day will be considered 'yes' if the participant completes a daily survey.

Countries

United States

Contacts

CONTACTJeffrey Zonder, MD
zonderj@karmanos.org313-576-8732
PRINCIPAL_INVESTIGATORJeffrey Zonder, MD

Barbara Ann Karmanos Cancer Institute

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 27, 2026