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
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
60 participants
Nov 21, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- Aged 18-80 years (inclusive), regardless of gender;
- ICU inpatients with a serum phosphate concentration \<0.80 mmol/L, and for whom the clinician determines phosphate supplementation is required;
- Ability to receive enteral nutrition, with a daily enteral caloric intake ≥10 kcal/kg/day;
- The subject or their legal guardian fully understands the purpose and significance of this trial, voluntarily agrees to participate, provides written informed consent, and is willing to strictly adhere to the clinical study protocol and complete the study.
Exclusion Criteria8
- Pregnant and lactating women;
- Patients with 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 ≤96 hours;
- Known allergy to any component of the investigational drug or drugs with a similar chemical structure;
- Severe renal impairment: estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m²;
- Subjects with hyperthyroidism requiring clinical intervention;
- Subjects requiring sodium restriction;
- Other conditions deemed by the investigator as unsuitable for inclusion.
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Interventions
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.
Locations(1)
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NCT07233889