Enteral phosphate granules to treat low blood phosphate (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

This trial will test whether giving enteral sodium dihydrogen phosphate and disodium hydrogen phosphate granules to adult ICU patients with low blood phosphate raises their serum phosphorus and is safe.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (Academic / other)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT07233889 on ClinicalTrials.gov

What this trial studies

Critically ill adult inpatients with mild to severe hypophosphatemia (serum phosphate <0.80 mmol/L) will receive enteral sodium dihydrogen phosphate and disodium hydrogen phosphate granules by mouth or via nasogastric tube. Doses will vary by severity and be given daily for up to 14 days while clinicians monitor serum phosphorus and clinical status. The primary outcomes are change in serum phosphate levels and the occurrence of gastrointestinal complications. The trial is single-center and conducted in the ICU at Union Hospital, Tongji Medical College in Wuhan, Hubei.

Who should consider this trial

Good fit: Adults 18–80 years old in the ICU with serum phosphate <0.80 mmol/L who can receive enteral nutrition (≥10 kcal/kg/day) and for whom the treating clinician has decided phosphate supplementation is required.

Not a fit: Patients who cannot receive enteral feeds (for example due to acute upper GI bleeding, intestinal obstruction, severe pancreatitis, digestive tract fistula, or enteral feeding intolerance), pregnant or lactating women, or those expected to leave the ICU within 96 hours are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, enteral phosphate granules could restore low blood phosphate levels using an oral or tube route and reduce complications related to hypophosphatemia.

How similar studies have performed: Enteral phosphate replacement has been used in non-ICU settings and can raise serum phosphate, but high-quality randomized data in critically ill ICU populations are limited.

Eligibility criteria

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.

Where this trial is running

Wuhan, Hubei

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Yuan Yu, Ph.D., M.D.

Conditions Hypophosphatemia; Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules