Enteral Supplementation With Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules for the Treatment of Hypophosphatemia.

NCT07233889 | Recruiting DMC

• 1 other identifier: ICU202501
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypophosphatemia

Keywords

Hypophosphatemia; Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules

Outcome Measures

Primary Outcomes (1)

• 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.

  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 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

  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.

  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

  During the study period, the maximum duration shall not exceed 14 days.

• Incidence of Adverse Reactions

  The entire duration of the study, from initiation to completion, shall not exceed 14 days.

Study Arms (3)

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.

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.

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.

Drug: Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules

Interventions

Sodium Dihydrogen Phosphate and Disodium Hydrogen Phosphate Granules DRUG

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.

Mild Hypophosphatemia Group; Moderate Hypophosphatemia Group; Severe Hypophosphatemia Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

RECRUITING

Related Publications (12)

• 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.

  PMID: 34705137 RESULT

• Kaya 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.

  PMID: 36065653 RESULT

• Felsenfeld 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.

  PMID: 22863286 RESULT

• Geerse 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.

  PMID: 20682049 RESULT

• Nguyen 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.

  PMID: 38537225 RESULT

• Engwerda 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.

  PMID: 30569887 RESULT

• Lair 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.

  PMID: 37042685 RESULT

• Rubio-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.

  PMID: 35511366 RESULT

• Dickerson 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.

  PMID: 11334065 RESULT

• Daily 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.

  PMID: 2225887 RESULT

• Cohen 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.

  PMID: 15296888 RESULT

• Hoffmann 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.

  PMID: 18820097 RESULT

MeSH Terms

Conditions

Hypophosphatemia

Interventions

sodium phosphate

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Yuan Yu, Ph.D., M.D.

CONTACT

86+13971256590; yuyuanwhuh@hust.edu.cn

Zhuanyun Li, Ph.D., M.D.

CONTACT

86+15199108915; 2577008209@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Internal medicine physician

Model Details: 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.

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: November 18, 2025
• Study Start: November 21, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)