Individualized Study of Refeeding to Optimize iNpatient Gains

Study acronym: i-STRONG
StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Results posted: Sep 25, 2026 Show 6 more changesShow less
    • Trial status changed: Enrolling by Invitation → Completed
    • Study completion date changed from estimate of Mar 31, 2026 to Jun 3, 2026
    • Enrollment target: estimated 74 to confirmed 77
    • Secondary endpoint revised
    • Site details revised at 2 of 2 sites
    • Eligibility criteria shortened, about 4 words
  2. Re-verified, no change to tracked fieldsv9
  3. Primary completion date changed from estimate of Mar 31, 2025 to Jun 3, 2025v8
  4. Primary completion date: Nov 30, 2024 to Mar 31, 2025
    • Study completion date: Apr 14, 2026 to Mar 31, 2026
    v7
  5. Primary completion date: Nov 2024 to Nov 30, 2024
    • Start date: Oct 28, 2021 to Oct 12, 2021
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Re-verified, no change to tracked fieldsv5
  2. Start date: Oct 12, 2021 to Oct 28, 2021v4
  3. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Start date changed from estimate of Sep 2021 to Oct 12, 2021
    • Site contacts updated at 1 of 2 sites
    v3
  4. Start date: Jul 2021 to Sep 2021
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description expanded, about 2 words
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The primary purpose of the trial is to compare the efficacy and safety of Individualized Caloric Refeeding (ICR) to the new standard of care, Higher Calorie Refeeding (HCR), in hospitalized patients with atypical anorexia nervosa (AAN), and clinical remission over one year of follow-up.
Trial Details
NCT Number NCT04966858
Lead Sponsor University of California, San Francisco
Collaborators: Stanford University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions
(from sponsor)		 Atypical Anorexia Nervosa
Related terms Malnutrition
Enrollment 77 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov