Dietary Reporting In The Amyloidoses

Amyloidosis Clinical Trial

— DRITA  

Official title:

DRITA Pilot Trial: Dietary Reporting in the Amyloidoses

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05738005
• Other study ID #: 2022-067
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2023
• Est. completion date: November 21, 2025

Study information

• Verified date: May 2023
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: Jeffrey Zonder, MD
• Phone: 313-576-8732
• Email: zonderj[@]karmanos.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 21, 2025
• Est. primary completion date: November 21, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyloidosis

Intervention

Other:
• Tracking 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.

Locations

Country	Name	City	State
United States	Karmanos Cancer Institute	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Barbara Ann Karmanos Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence Rate	The 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.	56 days
Secondary	Subsequent adherence rate	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.	63 days (= 56 days + Week 10)