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

42 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug Sodium Glycerophosphate Injection and Sodium Phosphates Injection for intravenous nutrition?

Research shows that sodium glycerophosphate is safe and works similarly to inorganic phosphate in the body, and it helps improve mineral metabolism in very small infants when used in intravenous nutrition. ^{1 2 3 4 5}

Is it safe to use phosphate injections for intravenous nutrition?

Research suggests that sodium glycerophosphate and inorganic sodium phosphate are generally safe for intravenous use, but there are risks of electrolyte imbalances, especially in smaller individuals or those with certain health conditions. It's important to monitor for potential side effects like high phosphate levels, which can affect calcium levels in the body. ^{1 2 3 6 7}

How is the drug Sodium Glycerophosphate Injection different from other treatments for intravenous nutrition?

Sodium Glycerophosphate Injection is unique because it can be used interchangeably with inorganic phosphate, offering similar safety and absorption in the body. It is particularly beneficial in improving mineral metabolism in extremely low birth weight infants when used in parenteral (intravenous) nutrition. ^{1 2 3 8 9}

What is the purpose of this trial?

This is a phase 1, prospective, single-center, randomized sequence, double-blind, 2-way crossover, relative bioavailability study in healthy adult subjects comparing Sodium Glycerophosphate Injection (SGP) to Sodium Phosphate Injection (NaP). In this study it is planned to randomize approximately 42 healthy male and female subjects. All study periods will be completed during a single residency, the overall duration of residency will be 11 days (10 nights).

Research Team

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

Principal Investigator

Baxter Healthcare Corporation

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Extended Stability of Sodium Phosphate Solutions in Polyvinyl Chloride Bags. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Glycerophosphate is interchangeable with inorganic phosphate in terms of safety and serum pharmacokinetics. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Sodium Glycerophosphate Use in Parenteral Nutrition Improves Mineral Metabolism in Extremely Low Birth Weight Infants. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

A novel phosphorus repletion strategy in a patient with duodenal perforation. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Physical Compatibility of Sodium Glycerophosphate and Calcium Gluconate in Pediatric Parenteral Nutrition Solutions. [2015]

6. England 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. [2013]

7. Canada pubmed.ncbi.nlm.nih.gov

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

8. England pubmed.ncbi.nlm.nih.gov

Hypophosphataemia and phosphorus requirements during intravenous nutrition. [2019]

9. Mexico pubmed.ncbi.nlm.nih.gov

[Changes of serum lipids during parenteral feeding with a 10 percent of soy oil solution (author's transl)]. [2023]