NCT07233889

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

A Prospective Clinical Study Evaluating the Effectiveness and Safety of Enteral Supplementation With Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules for Varying Degrees of Hypophosphatemia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

• Hypophosphatemia

Interventions

Type	Name	Description
DRUG	Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules	After signing the informed consent form (ICF), eligible subjects were stratified based on the severity of hypophosphatemia during the screening period: mild hypophosphatemia (0.65-0.80 mmol/L), moderate hypophosphatemia (0.32-0.64 mmol/L), or severe hypophosphatemia (\<0.32 mmol/L). Following enrollment, subjects entered a treatment period of up to 14 days. All subjects received a differentiated phosphate supplementation strategy based on actual body weight: subjects with mild hypophosphatemia received 0.306 mmol/(kg·d); those with moderate hypophosphatemia received 0.612 mmol/(kg·d); and those with severe hypophosphatemia received 0.816 mmol/(kg·d). During the treatment period, venous blood was drawn daily between 5:00 and 6:00 AM to measure serum phosphorus levels and evaluate the efficacy of supplementation. Based on the daily serum phosphorus level, the investigator determined the severity of hypophosphatemia and administered the corresponding phosphate dose.

Timeline

• Start date: 2025-11-21
• Primary completion: 2026-05-31
• Completion: 2026-06-30
• First posted: 2025-11-18
• Last updated: 2025-11-28

Locations

1 site across 1 country: China