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

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

Status: Enrolling

Conditions: Hypophosphatemia

Treatments: Drug: Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules

Study type: Interventional

Funder types: Other

Identifiers

NCT07233889

ICU202501

Details and patient eligibility

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged 18-80 years (inclusive), regardless of gender;
2. ICU inpatients with a serum phosphate concentration <0.80 mmol/L, and for whom the clinician determines phosphate supplementation is required;
3. Ability to receive enteral nutrition, with a daily enteral caloric intake ≥10 kcal/kg/day;
4. 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 criteria

1. Pregnant and lactating women;
2. 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;
3. Expected ICU stay ≤96 hours;
4. Known allergy to any component of the investigational drug or drugs with a similar chemical structure;
5. Severe renal impairment: estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m²;
6. Subjects with hyperthyroidism requiring clinical intervention;
7. Subjects requiring sodium restriction;
8. Other conditions deemed by the investigator as unsuitable for inclusion.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups

Mild Hypophosphatemia Group

Experimental group

Description:

Mild hypophosphatemia is defined as a serum phosphorus level of 0.65-0.80 mmol/L. For subjects with mild hypophosphatemia, the phosphorus supplementation dose is 0.306 mmol/(kg·d) based on the subject's actual body weight. During treatment, venous blood is drawn daily between 5:00 and 6:00 AM to measure serum phosphorus levels and evaluate the effectiveness of supplementation. The investigator determines the severity of hypophosphatemia based on the day's serum phosphorus level and administers the corresponding phosphorus supplementation dose for mild, moderate, or severe cases.

Treatment:

Drug: Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules

Moderate Hypophosphatemia Group

Experimental group

Description:

Moderate hypophosphatemia is defined as a serum phosphorus level of 0.32-0.64 mmol/L. For subjects with moderate hypophosphatemia, the phosphorus supplementation dose is 0.612 mmol/(kg·d) based on the subject's actual body weight. During treatment, venous blood is drawn daily between 5:00 and 6:00 AM to measure serum phosphorus levels and evaluate the effectiveness of supplementation. The investigator determines the severity of hypophosphatemia based on the day's serum phosphorus level and administers the corresponding phosphorus supplementation dose for mild, moderate, or severe cases.

Treatment:

Drug: Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules

Severe Hypophosphatemia Group

Experimental group

Description:

Severe hypophosphatemia is defined as a serum phosphate level \<0.32 mmol/L. For subjects with severe hypophosphatemia, the phosphorus supplementation dose is 0.816 mmol/(kg·d) based on the subject's actual body weight. During treatment, venous blood is drawn daily between 5:00 and 6:00 AM to measure serum phosphorus levels and evaluate the effectiveness of supplementation. The investigator determines the severity of hypophosphatemia based on the day's serum phosphorus level and administers the corresponding phosphorus supplementation dose for mild, moderate, or severe cases.

Treatment:

Drug: Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules