HypophosphatemiaNCT07233889
Enteral Supplementation With Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules for the Treatment of Hypophosphatemia.
A study testing Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules in people with Hypophosphatemia, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypophosphatemia
- What is being tested?
- Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 21 Nov 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
- Known allergy to any component of the investigational drug or drugs with a similar chemical structure;
- Severe renal impairment: estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m²;
- Subjects with hyperthyroidism requiring clinical intervention;
- Subjects requiring sodium restriction;
- Other conditions deemed by the investigator as unsuitable for inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Zhuanyun Li, Ph.D., M.D., 86+15199108915, 2577008209@qq.com
About this study
Official title: 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
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.
- Conditions
- Hypophosphatemia
- Being tested
- Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules
- Keywords
- Hypophosphatemia, Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules
- Medical subject headings
- Hypophosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate GranulesDrug
After signing the informed consent form (ICF), eligible subjects were stratified based on the severity of hypophosphatemia during the screening period: mild hypophosphatemia (0.65-0.80 mmol/L), moderate hypophosphatemia (0.32-0.64 mmol/L), or severe hypophosphatemia (<0.32 mmol/L).
Following enrollment, subjects entered a treatment period of up to 14 days. All subjects received a differentiated phosphate supplementation strategy based on actual body weight: subjects with mild hypophosphatemia received 0.306 mmol/(kg·d); those with moderate hypophosphatemia received 0.612 mmol/(kg·d); and those with severe hypophosphatemia received 0.816 mmol/(kg·d). During the treatment period, venous blood was drawn daily between 5:00 and 6:00 AM to measure serum phosphorus levels and evaluate the efficacy of supplementation. Based on the daily serum phosphorus level, the investigator determined the severity of hypophosphatemia and administered the corresponding phosphate dose.
| Study group | Role | What they receive |
|---|---|---|
| Mild Hypophosphatemia Group | Experimental | 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. Receives: Drug: Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules |
| Moderate Hypophosphatemia Group | Experimental | 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. Receives: Drug: Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules |
| Severe Hypophosphatemia Group | Experimental | 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. Receives: Drug: Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of achieving target serum phosphorus levels (≥0.80 mmol/L) with enteral phosphorus supplementation in patients during the study period.
Among patients receiving enteral phosphate supplementation during the study period, the proportion achieving the target serum phosphate level (≥0.80 mmol/L). This proportion ranges from 0% to 100%, with a higher value indicating better treatment efficacy of enteral phosphate supplementation.
Measured: Within 14 days of study enrollment
Secondary outcomes (6)
The magnitude of serum phosphorus elevation per 1 mmol of enteral phosphorus supplementation in patients during the study period.
The magnitude of serum phosphorus elevation per 1 mmol of enteral phosphorus supplementation in patients during the study period. A greater magnitude of serum phosphorus elevation indicates better treatment efficacy of phosphorus supplementation.
Measured: The total duration from the start of enteral phosphorus supplementation to the end of phosphorus therapy is less than 14 days.
Average time to achieve target serum phosphorus concentration during phosphorus replacement therapy
Average time to achieve target serum phosphorus concentration during phosphorus replacement therapy. A shorter time indicates better efficacy of phosphorus supplementation.
Measured: The total duration from the initiation of enteral phosphate supplementation to the normalization of serum phosphate levels is less than 14 days.
The proportion of patients with a blood phosphorus concentration increase of less than 0.1 mmol/L over any 72-hour period during phosphorus supplementation therapy.
The proportion of patients with a blood phosphorus concentration increase of less than 0.1 mmol/L over any 72-hour period during phosphorus supplementation therapy. This proportion reflects the efficacy of phosphorus replacement therapy, with a higher proportion indicating poorer treatment response in more patients.
Measured: From the initiation of enteral phosphate supplementation to the end of treatment, the increase in serum phosphate levels within any 72-hour period occurs over a total duration of less than 14 days.
Proportion of withdrawals due to intolerance to enteral phosphorus supplementation
Proportion of withdrawals due to intolerance to enteral phosphorus supplementation. A lower withdrawal rate indicates the successful selection of the study population.
Measured: During the study period, the maximum duration shall not exceed 14 days.
Incidence of Adverse Reactions
The incidence of adverse reactions primarily includes discomfort symptoms such as diarrhea, abdominal pain, nausea, and vomiting.
Measured: The entire duration of the study, from initiation to completion, shall not exceed 14 days.
Changes in APACHE II and SOFA scores from baseline
Changes from baseline in the Acute Physiology and Chronic Health Evaluation (APACHE II) score and Sequential Organ Failure Assessment (SOFA) score. The APACHE II score ranges from 0 to 71 points, with higher scores indicating greater mortality risk. The SOFA score ranges from 0 to 24 points, where higher scores reflect more severe organ dysfunction and indicate a more critical patient condition.
Measured: APACHE II and SOFA scores within 24 hours before the start of the study and within 24 hours before the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start21 Nov 2025
- Primary completion31 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for HypophosphatemiaStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All participants with hypophosphatemia were enrolled in this study and stratified according to the severity of hypophosphatemia: mild hypophosphatemia (0.65-0.80 mmol/L), moderate hypophosphatemia (0.32-0.64 mmol/L), and severe hypophosphatemia (\<0.32 mmol/L). All subjects received differentiated phosphorus supplementation strategies: subjects with mild hypophosphatemia were administered 0.306 mmol/(kg·d); subjects with moderate hypophosphatemia received 0.612 mmol/(kg·d); and subjects with severe hypophosphatemia received 0.816 mmol/(kg·d). During the treatment period, venous blood samples were collected from subjects to measure blood phosphorus levels to evaluate the effect of phosphorus supplementation.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang xiaorong, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07233889
- Sponsor's protocol ID
- ICU202501
- Status last verified
- Nov 2025
- First submitted
- 23 Sep 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Cheng YC, Beh JY, Wu PH, Tsai NY, Jao SW. Early botulinum toxin injection reduces pain after hemorrhoidectomy: a pilot study. Tech Coloproctol. 2022 Jan;26(1):53-60. doi: 10.1007/s10151-021-02542-4. Epub 2021 Oct 27.
PubMed 34705137Kaya U, Dal Yilmaz U. Ideal Suggestions for Discharge Training and Telephone Counseling of Patients With Coronary Artery Bypass Graft Surgery: A Randomized Controlled and Experimental Study. J Korean Med Sci. 2022 Sep 5;37(35):e269. doi: 10.3346/jkms.2022.37.e269.
PubMed 36065653Felsenfeld AJ, Levine BS. Approach to treatment of hypophosphatemia. Am J Kidney Dis. 2012 Oct;60(4):655-61. doi: 10.1053/j.ajkd.2012.03.024. Epub 2012 Aug 3.
PubMed 22863286Geerse DA, Bindels AJ, Kuiper MA, Roos AN, Spronk PE, Schultz MJ. Treatment of hypophosphatemia in the intensive care unit: a review. Crit Care. 2010;14(4):R147. doi: 10.1186/cc9215. Epub 2010 Aug 3.
PubMed 20682049Nguyen CD, Panganiban HP, Fazio T, Karahalios A, Ankravs MJ, MacIsaac CM, Rechnitzer T, Arno L, Tran-Duy A, McAlister S, Ali Abdelhamid Y, Deane AM. A Randomized Noninferiority Trial to Compare Enteral to Parenteral Phosphate Replacement on Biochemistry, Waste, and Environmental Impact and Healthcare Cost in Critically Ill Patients With Mild to Moderate Hypophosphatemia. Crit Care Med. 2024 Jul 1;52(7):1054-1064. doi: 10.1097/CCM.0000000000006255. Epub 2024 Mar 25.
PubMed 38537225Engwerda E, van den Berg M, Blans M, Bech A, de Boer H. Efficacy and safety of a phosphate replacement strategy for severe hypophosphatemia in the ICU. Neth J Med. 2018 Dec;76(10):437-441.
PubMed 30569887Lair CS, Brown LS, Edwards A, Jacob T, Brion LP, Jaleel M. Quality improvement project in a neonatal intensive care unit reduced the prevalence and duration of hypophosphatemia with significant and sustainable results. Nutr Clin Pract. 2023 Dec;38(6):1379-1391. doi: 10.1002/ncp.10986. Epub 2023 Apr 12.
PubMed 37042685Rubio-Aliaga I, Krapf R. Phosphate intake, hyperphosphatemia, and kidney function. Pflugers Arch. 2022 Aug;474(8):935-947. doi: 10.1007/s00424-022-02691-x. Epub 2022 May 5.
PubMed 35511366Dickerson RN, Gervasio JM, Sherman JJ, Kudsk KA, Hickerson WL, Brown RO. A comparison of renal phosphorus regulation in thermally injured and multiple trauma patients receiving specialized nutrition support. JPEN J Parenter Enteral Nutr. 2001 May-Jun;25(3):152-9. doi: 10.1177/0148607101025003152.
PubMed 11334065Daily WH, Tonnesen AS, Allen SJ. Hypophosphatemia--incidence, etiology, and prevention in the trauma patient. Crit Care Med. 1990 Nov;18(11):1210-4. doi: 10.1097/00003246-199011000-00004.
PubMed 2225887Cohen J, Kogan A, Sahar G, Lev S, Vidne B, Singer P. Hypophosphatemia following open heart surgery: incidence and consequences. Eur J Cardiothorac Surg. 2004 Aug;26(2):306-10. doi: 10.1016/j.ejcts.2004.03.004.
PubMed 15296888Hoffmann M, Zemlin AE, Meyer WP, Erasmus RT. Hypophosphataemia at a large academic hospital in South Africa. J Clin Pathol. 2008 Oct;61(10):1104-7. doi: 10.1136/jcp.2007.054940.
PubMed 18820097
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07233889
- Acronym / sponsor ID
- ICU202501
- Conditions
- Hypophosphatemia
- Keywords
- Hypophosphatemia, Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 21 Nov 2025 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- All participants with hypophosphatemia were enrolled in this study and stratified according to the severity of hypophosphatemia: mild hypophosphatemia (0.65-0.80 mmol/L), moderate hypophosphatemia (0.32-0.64 mmol/L), and severe hypophosphatemia (<0.32 mmol/L). All subjects received differentiated phosphorus supplementation strategies: subjects with mild hypophosphatemia were administered 0.306 mmol/(kg·d); subjects with moderate hypophosphatemia received 0.612 mmol/(kg·d); and subjects with severe hypophosphatemia received 0.816 mmol/(kg·d). During the treatment period, venous blood samples were collected from subjects to measure blood phosphorus levels to evaluate the effect of phosphorus supplementation.
| Arm | Type | Receives |
|---|---|---|
| Mild Hypophosphatemia Group | Experimental | Drug: Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate GranulesMild 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. |
| Moderate Hypophosphatemia Group | Experimental | Drug: Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate GranulesModerate 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. |
| Severe Hypophosphatemia Group | Experimental | Drug: Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate GranulesSevere 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
- Known allergy to any component of the investigational drug or drugs with a similar chemical structure;
- Severe renal impairment: estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m²;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate GranulesAfter signing the informed consent form (ICF), eligible subjects were stratified based on the severity of hypophosphatemia during the screening period: mild hypophosphatemia (0.65-0.80 mmol/L), moderate hypophosphatemia (0.32-0.64 mmol/L), or severe hypophosphatemia (<0.32 mmol/L). Following enrollment, subjects entered a treatment period of up to 14 days. All subjects received a differentiated phosphate supplementation strategy based on actual body weight: subjects with mild hypophosphatemia received 0.306 mmol/(kg·d); those with moderate hypophosphatemia received 0.612 mmol/(kg·d); and those with severe hypophosphatemia received 0.816 mmol/(kg·d). During the treatment period, venous blood was drawn daily between 5:00 and 6:00 AM to measure serum phosphorus levels and evaluate the efficacy of supplementation. Based on the daily serum phosphorus level, the investigator determined the severity of hypophosphatemia and administered the corresponding phosphate dose. | Drug | Mild Hypophosphatemia Group, Moderate Hypophosphatemia Group, Severe Hypophosphatemia Group |
Primary outcome
The rate of achieving target serum phosphorus levels (≥0.80 mmol/L) with enteral phosphorus supplementation in patients during the study period.
Time frame: Within 14 days of study enrollment
Among patients receiving enteral phosphate supplementation during the study period, the proportion achieving the target serum phosphate level (≥0.80 mmol/L). This proportion ranges from 0% to 100%, with a higher value indicating better treatment efficacy of enteral phosphate supplementation.
6 secondary outcomes
The magnitude of serum phosphorus elevation per 1 mmol of enteral phosphorus supplementation in patients during the study period.
Time frame: The total duration from the start of enteral phosphorus supplementation to the end of phosphorus therapy is less than 14 days.
Average time to achieve target serum phosphorus concentration during phosphorus replacement therapy
Time frame: The total duration from the initiation of enteral phosphate supplementation to the normalization of serum phosphate levels is less than 14 days.
The proportion of patients with a blood phosphorus concentration increase of less than 0.1 mmol/L over any 72-hour period during phosphorus supplementation therapy.
Time frame: From the initiation of enteral phosphate supplementation to the end of treatment, the increase in serum phosphate levels within any 72-hour period occurs over a total duration of less than 14 days.
Proportion of withdrawals due to intolerance to enteral phosphorus supplementation
Time frame: During the study period, the maximum duration shall not exceed 14 days.
Incidence of Adverse Reactions
Time frame: The entire duration of the study, from initiation to completion, shall not exceed 14 days.
Changes in APACHE II and SOFA scores from baseline
Time frame: APACHE II and SOFA scores within 24 hours before the start of the study and within 24 hours before the end of the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Results publication: PubMed 34705137Cheng YC, Beh JY, Wu PH, Tsai NY, Jao SW. Early botulinum toxin injection reduces pain after hemorrhoidectomy: a pilot study. Tech Coloproctol. 2022 Jan;26(1):53-60. doi: 10.1007/s10151-021-02542-4. Epub 2021 Oct 27.
- Results publication: PubMed 36065653Kaya U, Dal Yilmaz U. Ideal Suggestions for Discharge Training and Telephone Counseling of Patients With Coronary Artery Bypass Graft Surgery: A Randomized Controlled and Experimental Study. J Korean Med Sci. 2022 Sep 5;37(35):e269. doi: 10.3346/jkms.2022.37.e269.
- Results publication: PubMed 22863286Felsenfeld AJ, Levine BS. Approach to treatment of hypophosphatemia. Am J Kidney Dis. 2012 Oct;60(4):655-61. doi: 10.1053/j.ajkd.2012.03.024. Epub 2012 Aug 3.
- Results publication: PubMed 20682049Geerse DA, Bindels AJ, Kuiper MA, Roos AN, Spronk PE, Schultz MJ. Treatment of hypophosphatemia in the intensive care unit: a review. Crit Care. 2010;14(4):R147. doi: 10.1186/cc9215. Epub 2010 Aug 3.
- Results publication: PubMed 38537225Nguyen CD, Panganiban HP, Fazio T, Karahalios A, Ankravs MJ, MacIsaac CM, Rechnitzer T, Arno L, Tran-Duy A, McAlister S, Ali Abdelhamid Y, Deane AM. A Randomized Noninferiority Trial to Compare Enteral to Parenteral Phosphate Replacement on Biochemistry, Waste, and Environmental Impact and Healthcare Cost in Critically Ill Patients With Mild to Moderate Hypophosphatemia. Crit Care Med. 2024 Jul 1;52(7):1054-1064. doi: 10.1097/CCM.0000000000006255. Epub 2024 Mar 25.
- Results publication: PubMed 30569887Engwerda E, van den Berg M, Blans M, Bech A, de Boer H. Efficacy and safety of a phosphate replacement strategy for severe hypophosphatemia in the ICU. Neth J Med. 2018 Dec;76(10):437-441.
- Results publication: PubMed 37042685Lair CS, Brown LS, Edwards A, Jacob T, Brion LP, Jaleel M. Quality improvement project in a neonatal intensive care unit reduced the prevalence and duration of hypophosphatemia with significant and sustainable results. Nutr Clin Pract. 2023 Dec;38(6):1379-1391. doi: 10.1002/ncp.10986. Epub 2023 Apr 12.
- Results publication: PubMed 35511366Rubio-Aliaga I, Krapf R. Phosphate intake, hyperphosphatemia, and kidney function. Pflugers Arch. 2022 Aug;474(8):935-947. doi: 10.1007/s00424-022-02691-x. Epub 2022 May 5.
- Results publication: PubMed 11334065Dickerson RN, Gervasio JM, Sherman JJ, Kudsk KA, Hickerson WL, Brown RO. A comparison of renal phosphorus regulation in thermally injured and multiple trauma patients receiving specialized nutrition support. JPEN J Parenter Enteral Nutr. 2001 May-Jun;25(3):152-9. doi: 10.1177/0148607101025003152.
- Results publication: PubMed 2225887Daily WH, Tonnesen AS, Allen SJ. Hypophosphatemia--incidence, etiology, and prevention in the trauma patient. Crit Care Med. 1990 Nov;18(11):1210-4. doi: 10.1097/00003246-199011000-00004.
- Results publication: PubMed 15296888Cohen J, Kogan A, Sahar G, Lev S, Vidne B, Singer P. Hypophosphatemia following open heart surgery: incidence and consequences. Eur J Cardiothorac Surg. 2004 Aug;26(2):306-10. doi: 10.1016/j.ejcts.2004.03.004.
- Results publication: PubMed 18820097Hoffmann M, Zemlin AE, Meyer WP, Erasmus RT. Hypophosphataemia at a large academic hospital in South Africa. J Clin Pathol. 2008 Oct;61(10):1104-7. doi: 10.1136/jcp.2007.054940.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules in people with Hypophosphatemia, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuan Yu, Ph.D., M.D. (86+13971256590, yuyuanwhuh@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of achieving target serum phosphorus levels (≥0.80 mmol/L) with enteral phosphorus supplementation in patients during the study period. (time frame: Within 14 days of study enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07233889, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.