Phosphate Injections for Intravenous Nutrition

Overseen By Clinical Research Manager

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Baxter Healthcare Corporation

Must not be taking: Antidepressants, Antipsychotics, others

Disqualifiers: Diabetes, Hypertension, Renal impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 31

Duration: 11 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of phosphate injections to evaluate how the body absorbs them, focusing on options for intravenous nutrition. The trial compares Sodium Glycerophosphate Injection and Sodium Phosphates Injection in healthy adults. Participants will receive both treatments in different sequences to measure absorption differences. Ideal candidates are healthy individuals who do not use tobacco or drugs and have no serious health conditions. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive these new treatments.

Will I have to stop taking my current medications?

Yes, participants must stop taking any prescribed or over-the-counter drugs or herbal remedies (except for up to 4 g per day of acetaminophen and hormonal contraception) within the last 30 days or five half-lives before the study medication is given. Exceptions may be made on a case-by-case basis if the investigator believes they won't interfere with the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Sodium Glycerophosphate Injection is usually well-tolerated, with no reported side effects, even in large amounts. This finding is encouraging for those needing intravenous nutrition, as they handle this treatment well.

Conversely, Sodium Phosphates Injection requires caution. It is safe for most people but not recommended for those with high phosphorus or low calcium levels. Individuals with excess sodium in their blood should also avoid it. However, it is generally not linked to cancer risks.

Both treatments have been tested in various settings and are typically safe. Participants should feel reassured, but consulting a doctor about personal health conditions before joining a trial is always best. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these phosphate injections for intravenous nutrition because they offer a fresh approach to how the body can receive essential nutrients. While traditional options often rely on standard sodium phosphates, this trial is exploring both an organic form, sodium glycerophosphate, and the usual inorganic form. The organic phosphate may offer improved absorption and utilization by the body, potentially leading to better nutrition outcomes. This dual approach could reveal which type of phosphate is more effective or beneficial, potentially setting a new standard for intravenous nutrient delivery.

What evidence suggests that this trial's treatments could be effective?

This trial will compare the effects of Sodium Glycerophosphate (SGP) and Sodium Phosphates Injection (NaP) in intravenous nutrition. Research has shown that Sodium Glycerophosphate can significantly raise calcium and phosphate levels more effectively than other phosphate sources. In studies, patients who received SGP had higher levels of these minerals in their blood after two weeks, demonstrating its effectiveness in increasing these vital minerals for strong bones and overall health.

Sodium Phosphate, on the other hand, effectively provides the necessary phosphorus in intravenous nutrition. It safely helps maintain balanced mineral levels in the body. Both treatments in this trial aim to improve mineral intake and balance, crucial for individuals requiring intravenous nutrition. Participants will receive either SGP followed by NaP or NaP followed by SGP, allowing for a direct comparison of their effects. ^{6 7 8 9 10}

Who Is on the Research Team?

Erika Ryan, DCN, MS, RD, CDN, CNSC

Principal Investigator

Baxter Healthcare Corporation

Are You a Good Fit for This Trial?

This trial is for healthy adult men and women who can stay at the study center for 11 days. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study.

Inclusion Criteria

I am a healthy adult between 18 and 55 years old and not pregnant or breastfeeding.

Must be willing and able to comply with all study requirements including dietary requirements

Subject must be literate, has signed a written informed consent form (ICF) and has the ability to communicate and comply with all study requirements

Exclusion Criteria

My kidneys are not working properly.

I have a history of bleeding ulcers or blood clotting issues.

I haven't taken any experimental drugs within the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 2-way crossover study comparing Sodium Glycerophosphate Injection to Sodium Phosphate Injection

11 days

Continuous residency for 11 days (10 nights)

Follow-up

Participants are monitored for safety and effectiveness after treatment

9 days

Monitoring through Day 20

What Are the Treatments Tested in This Trial?

Interventions

• Sodium Glycerophosphate Injection
• Sodium Phosphates Injection

Trial Overview The trial is testing if Sodium Glycerophosphate Injection (SGP) works the same way in your body as Sodium Phosphates Injection (NaP). It's a phase 1 study where participants will receive both treatments in different periods to compare their effects.

How Is the Trial Designed?

Group I: Sequence BA (Inorganic phosphate/ Organic phosphate) Experimental Treatment 2 Interventions

* Period 1: Regimen B (Inorganic phosphate (Sodium Phosphates Injection NaP)) * Period 2: Regimen A (Organic phosphate (sodium glycerophosphate SGP))

Group II: Sequence AB (Organic phosphate/ Inorganic phosphate) Experimental Treatment 2 Interventions

* Period 1: Regimen A (Organic phosphate (sodium glycerophosphate SGP)) * Period 2: Regimen B (Inorganic phosphate (Sodium Phosphates Injection NaP))

Who Is Running the Clinical Trial?

Baxter Healthcare Corporation

Lead Sponsor

Trials

328

Recruited

203,000+

Dr. Heather Knight

Baxter Healthcare Corporation

Chief Medical Officer

MD

Brent Shafer

Baxter Healthcare Corporation

Chief Executive Officer

Bachelor's degree in Business Administration

Published Research Related to This Trial

In a study involving 27 healthy volunteers, sodium glycerophosphate and sodium phosphate showed nearly identical pharmacokinetic profiles for inorganic phosphate in serum after intravenous administration, indicating they are essentially similar in how they behave in the body.

Both treatments were found to be safe, with only mild to moderate adverse events reported, and no serious adverse events occurred, suggesting good tolerability for both drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glycerophosphate is interchangeable with inorganic phosphate in terms of safety and serum pharmacokinetics. Topp, H., Hochfeld, O., Bark, S., et al.[2013]

Oral sodium phosphate is an effective and well-tolerated agent for colonic cleansing, as shown in multiple clinical trials, but it can cause shifts in intravascular volume and lead to hyperphosphatemia, which may result in hypocalcemia.

A review of cases at the authors' institution found four patients with adverse events related to oral sodium phosphate, primarily in those with pre-existing health conditions or who received higher doses than recommended, highlighting the need for careful patient selection and monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recognizing the clinical contraindications to the use of oral sodium phosphate for colon cleansing: a case study. Hookey, LC., Vanner, S.[2019]

Intravenous administration of lipids in patients receiving parenteral nutrition led to increased serum total lipids, triglycerides, and fatty acids, but did not alter serum cholesterol levels.

The use of heparin and insulin enhanced the clearance of plasma lipids, suggesting a safer profile by reducing the risk of complications like hyperlipemia and metabolic acidosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Changes of serum lipids during parenteral feeding with a 10 percent of soy oil solution (author's transl)]. Hernandez Lopez, D., Rivera Hidalgo, P., Guedea, MS., et al.[2023]

In a study of seven patients receiving intravenous nutrition with Intralipid, hypophosphataemia occurred, suggesting that the phosphorus in the fat emulsion may not be effectively absorbed.

The authors recommend increasing the phosphorus allowance to 0.5-0.75 mmol/kg body weight and advise routine serum phosphate monitoring for patients on intravenous nutrition to prevent potential complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypophosphataemia and phosphorus requirements during intravenous nutrition. Tovey, SJ., Benton, KG., Lee, HA.[2019]

The study tested the solubility of sodium glycerophosphate (NaGP) with calcium gluconate in pediatric parenteral nutrition solutions, finding that all tested concentrations (10-50 mEq/L for calcium and 10-50 mmol/L for NaGP) remained stable without precipitation or visual changes in 671 compounded solutions.

The results suggest that NaGP can safely replace sodium phosphate in pediatric parenteral nutrition, reducing the risk of calcium and phosphorus precipitation and simplifying the formulation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Compatibility of Sodium Glycerophosphate and Calcium Gluconate in Pediatric Parenteral Nutrition Solutions. MacKay, M., Anderson, C.[2015]

In a study of 172 extremely low birth weight infants, replacing potassium phosphate (K3PO4) with sodium glycerophosphate (NaGP) in parenteral nutrition significantly increased calcium and phosphorus intake, leading to improved serum levels of these minerals after 14 days.

The use of NaGP was associated with lower rates of electrolyte imbalances and clinical issues such as hypophosphatemia and bronchopulmonary dysplasia, particularly in infants who required prolonged parenteral nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sodium Glycerophosphate Use in Parenteral Nutrition Improves Mineral Metabolism in Extremely Low Birth Weight Infants. Hsu, PC., Tsao, PN., Chou, HC., et al.[2023]

Sodium phosphate solutions at concentrations of 30 and 150 mmol/L maintained over 94% of their initial sodium and phosphate concentrations for up to 63 days when stored at either 4°C or 23°C, indicating good chemical stability.

The study supports a beyond-use date of 14 days when refrigerated or 48 hours at room temperature for sodium phosphate injections, which aligns with safety guidelines, while suggesting that longer storage may be possible with validated sterility testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended Stability of Sodium Phosphate Solutions in Polyvinyl Chloride Bags. Perks, W., Iazzetta, J., Chan, PC., et al.[2022]

Smaller individuals (weighing <55 kg) experience significantly higher serum phosphate levels after consuming sodium phosphate preparations compared to larger individuals (weighing >100 kg), indicating a potential risk for complications.

The study suggests that lower body weight may increase the risk of calcium-phosphate nephropathy due to elevated phosphate levels, even when hydration is carefully monitored.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased serum phosphate levels and calcium fluxes are seen in smaller individuals after a single dose of sodium phosphate colon cleansing solution: a pharmacokinetic analysis. Ehrenpreis, ED.[2013]

In a case study, a patient on parenteral nutrition developed hypophosphatemia, highlighting the need for effective phosphate repletion methods when standard parenteral supplements are unavailable.

Using diluted hypertonic sodium phosphate enemas proved to be an effective and cost-efficient alternative for restoring phosphate levels, as phosphate is easily absorbed through the rectal mucosa, potentially preventing serious complications in similar patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel phosphorus repletion strategy in a patient with duodenal perforation. Kemmerly, T., Vuong, C., Kaunitz, JD.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36255046/

Sodium Glycerophosphate Use in Parenteral Nutrition ... Results: The use of NaGP instead of K3PO4 significantly increased Ca and P intake, but intakes remained below the recommended range (Ca, 64-140 mg/kg/day; P, 50 ...

2. jpeds.com jpeds.com/article/S0022-3476(22)00821-6/abstract

Sodium Glycerophosphate Use in Parenteral Nutrition ... Compared with levels in the K3PO4 group, the NaGP group had significantly higher serum Ca and P levels after day 14 and lower ALP levels after ...

3. mdpi.com mdpi.com/2227-9067/12/2/229

Sodium Glycerophosphate vs. Inorganic Phosphate Use in ... Results: During the first 4 weeks, the calcium and phosphate contents of parenteral nutrition were significantly higher in the sodium glycerophosphate vs.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11597339/

Outcomes for Patients Receiving Multi-Chamber Bags for the ... Five hospital-based and one home-based study reported that MCBs were well tolerated and provided adequate nutrition. Three hospital-based ...

5. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2014/200656Orig1s000ClinPharmR.pdf

200656Orig1s000 - accessdata.fda.gov Relative Bioavailability: Serum concentrations of phosphate steadily increased during the intravenous infusion and reached a peak at the end of ...

6. medsafe.govt.nz medsafe.govt.nz/profs/datasheet/g/Glycophosinf.pdf

Glycophos No adverse effects of an overdose have been reported. Most patients in need of intravenous nutrition have an increased capacity to handle glycerophosphate. See.

7. drugs.com drugs.com/pro/glycophos-injection.html

Glycophos Injection: Package Insert / Prescribing Info No adverse effects related to glycerophosphate have been reported. No adverse effects of an overdose have been reported. Most patients in need of intravenous ...

8. tga.gov.au tga.gov.au/sites/default/files/auspar-sodium-glycerophosphate-200213-pi.pdf

GLYCOPHOS - Sodium glycerophosphate (as hydrate) 4.9 Overdose​​ No adverse effects of an overdose have been reported. Most patients in need of intravenous nutrition have an increased capacity to ...

9. fresenius-kabi.com fresenius-kabi.com/content/dam/fresenius-kabi/nz/products/product-documents/parenteral-nutrition/Glycophos_Datasheet.pdf.coredownload.inline.pdf

PRODUCT INFORMATION No adverse effects of an overdose have been reported. Most patients in need of intravenous nutrition have an increased capacity to handle glycerophosphate. See.

10. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2014/200656Orig1s000MedR.pdf

200656Orig1s000 - accessdata.fda.gov Sodium glycerophosphate was well-tolerated following IV administration at doses higher than that to be administered at the maximum recommended dose of Kabiven ...