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NCT06651892

The Efficacy and Safety of Diluted Oral Phosphate Enema Versus Intravenous Sodium Glycerophosphate in The Treatment of Hypophosphatemia in ICU Patients

Completed Phase 2, PHASE3 Last updated 18 June 2025
What this trial tests

Phase 2, PHASE3 trial testing Enema Phosphates Sodium in Acute Hypophosphatemia in 42 participants. Completed in 30 December 2024.

Timeline
1 May 2024
Primary endpoint
30 December 2024
30 December 2024

Quick facts

Lead sponsorAin Shams University
PhasePhase 2, PHASE3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment42
Start date1 May 2024
Primary completion30 December 2024
Estimated completion30 December 2024
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

Sponsor

Ain Shams University

Who can join

18 and older, any sex, with Acute Hypophosphatemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical trial is to study the efficacy and safety of diluted phosphate enema in treating hypophosphatemia in adults in critical care unit in comparison to intravenous sodium glycero-phosphate as the current standard of care. The main question it aims to answer is: can the investigators rely on phosphate enemas as an effective and safe treatment option for hypophosphatemia in critically ill adults, in the era of global shortage of parenteral nutrition solutions and the absence of defined guidelines for treatment of acute hypophosphatemia in those population.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. The efficacy and safety of diluted oral phosphate enema versus intravenous sodium glycerophosphate in the treatment of hypophosphatemia in intensive care unit patients - A non-inferiority trial.
    Najdi H, Sayed R, Mettawi AS, El-Hamamsy M. · · 2025 · PMID 41242387 · DOI 10.1016/j.clnesp.2025.11.015

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