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Comparing Two Diets in Patients Undergoing HSCT or Remission Induction Chemo for Acute Leukemia and MDS (UF-BMT-LDND-101)

NCT03016130 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 217

Last updated 2025-04-07

No results posted yet for this study

Summary

This is an open-label, two-arm, phase III non-inferiority trial to evaluate the safety of a liberalized hospital diet inclusive of fresh fruits and vegetables to a neutropenic diet in patients with prolonged neutropenia. Both cohorts and diets will adhere to the hygiene and common sense advice listed in the FDA-endorsed food safety guidelines.

Conditions

Interventions

OTHER

Diet

Diet Intervention: Subjects will undergo stratified randomization to account for the heterogeneous population, to receive one of the two diets: liberalized hospital diet (Diet A) or a neutropenic diet (Diet B).

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Paul Crispen, MD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-18
Primary Completion
2023-05-29
Completion
2024-05-16

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT03016130 on ClinicalTrials.gov