Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT07233889

Enteral Supplementation With Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules for the Treatment of Hypophosphatemia.

Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2025-11-28

60

Participants Needed

1

Research Sites

31 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this clinical trial is to evaluate the efficacy and safety of Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules for the treatment of participants with mild, moderate, and severe hypophosphatemia. The main questions it aims to answer are: Does enteral supplementation of Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules elevate participants' serum phosphorus? Does enteral supplementation of Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules cause gastrointestinal complications? Participants with hypophosphatemia will receive Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules orally or via nasogastric tube to observe the efficacy and safety of enteral phosphate supplementation. Participants will take Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules daily, with varying doses based on the severity of hypophosphatemia, for a maximum of 14 days. The effect of phosphate supplementation will be assessed daily through blood draws, and their gastrointestinal symptoms will be recorded.

CONDITIONS

Official Title

Enteral Supplementation With Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules for the Treatment of Hypophosphatemia.

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18-80 years, any gender
  • ICU inpatients with serum phosphate concentration below 0.80 mmol/L requiring phosphate supplementation
  • Able to receive enteral nutrition with daily caloric intake of at least 10 kcal/kg
  • Fully understand the study purpose, voluntarily consent, and agree to follow the study protocol
Not Eligible

You will not qualify if you...

  • Pregnant or lactating women
  • Contraindications for enteral administration such as acute upper gastrointestinal bleeding, mechanical intestinal obstruction, severe acute pancreatitis, digestive tract fistula, gastrointestinal dysfunction, intra-abdominal hypertension, enteral feeding intolerance, or continuous gastrointestinal decompression
  • Expected ICU stay less than 96 hours
  • Known allergy to study drug components or similar drugs
  • Severe kidney impairment with eGFR below 30 mL/min/1.73m²
  • Hyperthyroidism requiring treatment
  • Need for sodium restriction
  • Other conditions making participation unsuitable as judged by the investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China, 430000

Actively Recruiting

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Research Team

Y

Yuan Yu, Ph.D., M.D.

CONTACT

Z

Zhuanyun Li, Ph.D., M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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