NCT07233889 Enteral Supplementation With Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules for the Treatment of Hypophosphatemia.
| NCT ID | NCT07233889 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
| Condition | Hypophosphatemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-11-21 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-11-21 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07233889 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Hypophosphatemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07233889 currently recruiting?
Yes, NCT07233889 is actively recruiting participants. Contact the research team at yuyuanwhuh@hust.edu.cn for enrollment information.
Where is the NCT07233889 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT07233889 clinical trial?
NCT07233889 is sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. The trial plans to enroll 60 participants.