Enteral Supplementation With Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules… (NCT07233889) | Clinical Trial Compass
RecruitingNot Applicable
Enteral Supplementation With Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules for the Treatment of Hypophosphatemia.
China60 participantsStarted 2025-11-21
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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;
✕
What they're measuring
1
The rate of achieving target serum phosphorus levels (≥0.80 mmol/L) with enteral phosphorus supplementation in patients during the study period.
Timeframe: Within 14 days of study enrollment
Trial details
NCT IDNCT07233889
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology