Enteral phosphate granules to treat low blood phosphate (hypophosphatemia)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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.
• Email: yuyuanwhuh@hust.edu.cn
• Phone: 86+13971256590

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Registry for patients with X-Linked Hypophosphatemia

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  Recruiting at 6 sites Kyowa Kirin Co., Ltd. · Brussels and 117 other locations · NCT03193476

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.