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Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Eligibility criteria expanded, about 29 wordsv9 See this version in full on ClinicalTrials.gov ↗
  2. Notable Trial status: Not Yet Recruiting to Recruiting Primary completion date: Mar 2028 to Aug 2027 · Completion date: Mar 2030 to Aug 2029 · Start date changed from estimate of Mar 2025 to Mar 25, 2025 · 1 morev8 Show 4 more changesShow less
    • Primary completion date: Mar 2028 to Aug 2027
    • Completion date: Mar 2030 to Aug 2029
    • Start date changed from estimate of Mar 2025 to Mar 25, 2025
    • Site details revised at 3 of 3 sites
  3. Minor Re-verified, no change to tracked fieldsv7
  4. Notable Primary completion date: Aug 2027 to Mar 2028 Start date: Nov 2024 to Mar 2025 · Completion date: Aug 2029 to Mar 2030v6 Show 2 more changesShow less
    • Start date: Nov 2024 to Mar 2025
    • Completion date: Aug 2029 to Mar 2030
  5. Minor Start date: Oct 2024 to Nov 2024v5
Show 3 earlier versionsHide 3 earlier versions
  1. Minor Eligibility criteria expanded, about 15 wordsv4 See this version in full on ClinicalTrials.gov ↗
  2. Notable Phase: Not applicable to Phase 2 Interventions: Placebo (Other), Vitamin A (Dietary Supplement) to Placebo (Other), Vitamin A (Drug)v3 Show 1 more changeShow less
    • Interventions: Placebo (Other), Vitamin A (Dietary Supplement) to Placebo (Other), Vitamin A (Drug)
  3. Notable Primary endpoint revised Secondary endpoints revised (3) · Study title shortened, about 6 words · Study description expanded, about 2 wordsv2 Show 3 more changesShow less
    • Secondary endpoints revised (3)
    • Study title shortened, about 6 words
    • Study description expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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 investigators hypothesize that single oral high dose supplementation with vitamin A will reduce the incidence of moderate-severe chronic graft-versus-host disease (GVHD) compared with placebo.
Trial Details
NCT Number NCT06450925
Lead Sponsor Children's Hospital Medical Center, Cincinnati
Conditions Graft Vs Host Disease, Vitamin A Deficiency, Vitamin D Deficiency
Enrollment 190 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov