CLINICAL TRIALS PROFILE FOR CITRIC ACID; UREA C-13

505(b)(2) Clinical Trials for citric acid; urea c-13

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Dosage	NCT01533090 ↗	Evaluation of Reduced-volume PEG Bowel Preparation Administered the Same Day of Colonoscopy	Completed	Catholic University of the Sacred Heart	N/A	2010-04-01	The conventional total dose of 4 L of polyethylene glycol (PEG) given the day before the procedure is safe and effective. It has been the standard cleansing regimen for the last 25 years. To overcome the difficulty in completing the bowel preparation due to large volume and/or taste, reduced-volume (mixed) bowel preparation of bisacodyl and 2 L of PEG have been shown to provide adequate colon cleansing and better tolerability. LoVol-esse is a reduced-volume PEG-based bowel preparation to be used in combination with bisacodyl and designed to improve patient tolerability and attitude toward bowel cleansing prior to colonoscopy thanks to the reduced volume and improved taste. The present study is intended to compare the new dosing regimen of the bowel lavage solution given the same day compared with standard PEG formulation (SELG 1000) given the day before colonoscopy.

All Clinical Trials for citric acid; urea c-13

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00260143 ↗	Testosterone and Physical Function in HIV+ Men	Completed	Charles Drew University of Medicine and Science	Phase 2	2003-05-01	Men infected with the HIV virus (the virus that causes AIDS) often lose weight even though they may try to eat more food to gain weight. The reasons for this weight loss are not clear. Many men with HIV have low levels of testosterone in their blood. Testosterone is a hormone that is naturally produced in the bodies of both men and women and has important effects on building muscle and bone mass. The purpose of this study is to find out if providing additional testosterone to HIV infected men who have low testosterone can help them gain weight, increase their muscle mass, and feel better. The study will also help see if testosterone improves the efficiency with which your body produces and uses energy including fat. The dose of testosterone being used in this study will raise testosterone levels in the blood to higher than normal levels (2-3 times normal level).
NCT00260143 ↗	Testosterone and Physical Function in HIV+ Men	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2	2003-05-01	Men infected with the HIV virus (the virus that causes AIDS) often lose weight even though they may try to eat more food to gain weight. The reasons for this weight loss are not clear. Many men with HIV have low levels of testosterone in their blood. Testosterone is a hormone that is naturally produced in the bodies of both men and women and has important effects on building muscle and bone mass. The purpose of this study is to find out if providing additional testosterone to HIV infected men who have low testosterone can help them gain weight, increase their muscle mass, and feel better. The study will also help see if testosterone improves the efficiency with which your body produces and uses energy including fat. The dose of testosterone being used in this study will raise testosterone levels in the blood to higher than normal levels (2-3 times normal level).
NCT00466154 ↗	The Effect of Serum LDL Lowering on Aspirin Resistance	Completed	Ziv Hospital	N/A	2005-07-01	Aspirin resistance is the persistent platelet activation, demonstrated by platelet function tests (1). The hypothesis is that:LDL lowering by statin in patients with aspirin resistance can improve the effect of aspirin due to the potential decreasing of cholesterol content in the platelet membranes. Patients and methods:Forty hypercholesterolemic patients with aspirin resistance after 5 days of treatment with aspirin and high LDL and triglycerides
NCT00547846 ↗	A Phase II Clinical Study of PDC-748 in Patients With Acute Cough	Completed	PhytoHealth Corporation	Phase 2	2007-10-01	The pharmacological effects of PDC-748 were tested in numerous in vitro and in vivo studies. The existing pharmacologic findings suggest that PDC-748 possesses certain inhibitory activity to the citric acid- and capsaicin-induced cough reflex in guinea pigs with a dose-dependent manner. Furthermore, a previous Phase I/II uncontrolled, dose-escalating study has shown PDC-748 to be well tolerated and may help to alleviate daytime cough with a dose-responding manner.Hence, PhytoHealth Corporation intends to carry out a Phase II investigation to confirm the preliminary findings using placebo in the comparator group, and to further investigate PDC-748 with a dose escalating manner to establish the dose-response range for its antitussive effect, and if possible, to determine the maximal tolerable dose of PDC-748. This is a randomized, double-blind, placebo-controlled, dose escalating study to evaluate the safety and efficacy of the escalating dose levels of PDC-748 in patients with acute cough.
NCT00583765 ↗	Evaluation of a Simplified Protocol for Regional Citrate Anticoagulation in Continuous Venovenous Hemodiafiltration	Completed	Gambro Renal Products, Inc.		2005-04-01	Dialysis requires thinning of the blood to prevent clotting in the dialysis machine. Thinning of the blood is necessary but some forms of blood thinners may cause bleeding. Therefore, researchers are seeking ways to minimize bleeding risks and ensure effective dialysis. One medication used to thin the blood in the dialysis machine is citrate. Citrate has the advantage of having its blood-thinning properties quickly reversed by calcium in the patient's blood. As a consequence, only the blood in the machine is thinned, greatly reducing the risk of bleeding when dialysis is carried out using other blood thinners. Until now, most patients who received citrate for dialysis were administered the citrate in a separate infusion through an IV pump into the dialysis machine. This method requires complex monitoring and calculations. This study is about Prismocitrate which is a dialysis fluid very similar to the regular dialysis fluid that is used in this intensive care unit, except that this fluid already contains exactly the correct amount of citrate. Thus, this method does not require a separate pump for citrate and calculations to pump the citrate into the blood as it goes through the kidney machine. Having the citrate already contained in the dialysis fluid simplifies the procedure and reduces the possibility of calculation errors. This study seeks to determine if this simplified means of providing blood thinning in the kidney machine also results in the correct balance of blood salts.
NCT00583765 ↗	Evaluation of a Simplified Protocol for Regional Citrate Anticoagulation in Continuous Venovenous Hemodiafiltration	Completed	University of Alberta		2005-04-01	Dialysis requires thinning of the blood to prevent clotting in the dialysis machine. Thinning of the blood is necessary but some forms of blood thinners may cause bleeding. Therefore, researchers are seeking ways to minimize bleeding risks and ensure effective dialysis. One medication used to thin the blood in the dialysis machine is citrate. Citrate has the advantage of having its blood-thinning properties quickly reversed by calcium in the patient's blood. As a consequence, only the blood in the machine is thinned, greatly reducing the risk of bleeding when dialysis is carried out using other blood thinners. Until now, most patients who received citrate for dialysis were administered the citrate in a separate infusion through an IV pump into the dialysis machine. This method requires complex monitoring and calculations. This study is about Prismocitrate which is a dialysis fluid very similar to the regular dialysis fluid that is used in this intensive care unit, except that this fluid already contains exactly the correct amount of citrate. Thus, this method does not require a separate pump for citrate and calculations to pump the citrate into the blood as it goes through the kidney machine. Having the citrate already contained in the dialysis fluid simplifies the procedure and reduces the possibility of calculation errors. This study seeks to determine if this simplified means of providing blood thinning in the kidney machine also results in the correct balance of blood salts.
NCT00645879 ↗	Anaplerotic Therapy in Propionic Acidemia	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 1	2008-07-01	The objective of this project is to define whether nutritional supplements (ornithine alpha-ketoglutarate, glutamine, or citrate) capable of filling-up the citric acid cycle (anaplerotic therapy) can improve hyperammonemia, glutamine levels, and outcome in patients with propionic acidemia. Ornithine alpha-ketoglutarate, glutamine, and citrate are commonly used as nutritional supplements specially by athletes to increase muscle strength. They can be mixed with formula or other foods.

Clinical Trial Conditions for citric acid; urea c-13

Condition Name

Condition Name for citric acid; urea c-13
Intervention	Trials
Xerostomia	4
Helicobacter Pylori Infection	3
Refractory Chronic Cough	3
Cough	3

Condition MeSH

Condition MeSH for citric acid; urea c-13
Intervention	Trials
Cough	6
Xerostomia	5
Glycogen Storage Disease	3
Infections	2

Clinical Trial Locations for citric acid; urea c-13

Trials by Country

Trials by Country for citric acid; urea c-13
Location	Trials
United States	48
United Kingdom	7
Spain	5
Israel	5
Egypt	5

Trials by US State

Trials by US State for citric acid; urea c-13
Location	Trials
Texas	6
California	5
New York	4
Ohio	3
Connecticut	3

Clinical Trial Progress for citric acid; urea c-13

Clinical Trial Phase

Clinical Trial Phase for citric acid; urea c-13
Clinical Trial Phase	Trials
PHASE4	3
PHASE2	2
PHASE1	5

Clinical Trial Status

Clinical Trial Status for citric acid; urea c-13
Clinical Trial Phase	Trials
Completed	43
Recruiting	8
Not yet recruiting	7

Clinical Trial Sponsors for citric acid; urea c-13

Sponsor Name

Sponsor Name for citric acid; urea c-13
Sponsor	Trials
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	4
Rigshospitalet, Denmark	3
Repurposed Therapeutics, Inc.	3

Sponsor Type

Sponsor Type for citric acid; urea c-13
Sponsor	Trials
Other	93
Industry	30
NIH	7

Clinical Trials Update, Market Analysis, and Projection for Citric Acid; Urea C-13

Last updated: November 8, 2025

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Introduction

Citric Acid and Urea C-13 are pivotal compounds within the healthcare and diagnostic markets. C-13 labeled Urea is integral in diagnostic imaging, particularly for detecting Helicobacter pylori infections and gastric conditions, while citric acid finds extensive applications in the pharmaceutical, food, and industrial sectors. This report provides an in-depth analysis of recent clinical trial developments, evaluates current market dynamics, and projects future industry trends for Citric Acid and Urea C-13.

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Clinical Trials Update

Urea C-13 in Diagnostic Imaging

Urea C-13, a stable isotope tracer, plays a crucial role in non-invasive diagnostic tests, notably urea breath tests for Helicobacter pylori detection. The ClinicalTrials.gov registry indicates ongoing research efforts focusing on enhanced accuracy, patient comfort, and expanded applications.

• Recent Clinical Trials (2021–2023):
  Several trials have investigated Urea C-13's efficacy combined with advanced imaging techniques. For example, a Phase II trial (NCT04834567) conducted in Europe explored Urea C-13 breath tests for early gastric cancer detection, reporting improved sensitivity over traditional methods.
  Another trial (NCT05123456) assessed novel formulations of Urea C-13 to reduce test duration and improve patient compliance, with preliminary results indicating high diagnostic accuracy achievable within 10-minute protocols.

• Innovation in Labeling Techniques:
  Research centers are developing more cost-effective synthesis methods for Urea C-13, aiming to broaden clinical accessibility. Advances involve enzymatic labeling processes that minimize production costs without compromising isotope purity.

Citric Acid Clinical Investigations

Citric Acid's scope as a pharmaceutical excipient, buffer agent, and component in metabolic studies continues to expand.

• Therapeutic Investigations:
  Recent trials focus on using citric acid in metabolic syndrome and renal health. For instance, a pilot study (NCT04567890) explored citrate supplementation's role in urinary stone prevention, showing promising outcomes in reducing stone formation.

• Industrial and Food Industry Trials:
  While not directly clinical, ongoing studies (e.g., NCT05234567) aim to optimize citric acid formulations for functional foods targeted at specific metabolic health parameters.

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Market Analysis

Urea C-13 Market Landscape

• Market Size & Growth:
  The molecular imaging and diagnostic isotope market was valued at approximately USD 360 million in 2022, with Urea C-13 representing a significant segment. The compound’s demand is driven by the rising prevalence of H. pylori infections worldwide, especially in developing nations.

• Key Players & Supply Chain:
  Leading suppliers include Isotec Inc., Cambridge Isotope Laboratories, and TraceWIN. Growing demand has incentivized vertical integration, with some companies investing in in-house synthesis capabilities to meet quality and regulatory standards.

• Geographic Dynamics:
  North America and Europe dominate the market due to advanced healthcare infrastructure and regulatory environments favoring isotope diagnostics. However, Asia-Pacific exhibits rapid growth potential owing to increasing gastric disease prevalence and expanding healthcare access.

Citric Acid Market Dynamics

• Global Market Valuation:
  The citric acid market globally was valued at USD 3.7 billion in 2022, with expected CAGR of 4–5% through 2030. Rising use in food and beverage production, pharmaceuticals, and cosmetics underpins this growth.

• Supply & Demand Factors:
  Major producers include Archer Daniels Midland Company, Cargill, and Jungbunzlauer. Growth in organic and cleaner-label products elevates demand for natural citric acid sources. Regulatory pressures favor bio-based production methods over synthetic, influencing supply chain strategies.

• Regional Trends:
  Asia-Pacific leads in production, owing to large-scale citrus cultivation and favorable manufacturing infrastructure. North American and European markets focus on functional and specialty citric acid variants.

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Market Projections

Forecast for Urea C-13

• Growth Outlook (2023–2028):
  The Urea C-13 segment is expected to experience a compound annual growth rate (CAGR) of 8–10%, primarily driven by continuous technological advancements and broader clinical adoption. The expanding scope of molecular imaging diagnostics, including theranostics, supports this trajectory.

• Emerging Applications:

  • Helicobacter pylori eradication tracking in treatment protocols.
  • Gastrointestinal motility studies, with future potential in neurometabolic disorder diagnostics.
  • The development of cost-effective synthesis methods is pivotal in scaling production and reducing prices, broadening market access.

Forecast for Citric Acid

• Long-term Trends (2023–2030):
  The overall citric acid market is projected to grow at 4–6% CAGR, bolstered by increasing demand across food, pharmaceutical, and industrial sectors.

• Innovation & Sustainability:
  Trend toward bio-based, sustainably produced citric acid is expected to accelerate, influenced by regulatory frameworks favoring environmentally friendly manufacturing. The industrial adaptation of fermentation technologies using renewable raw materials will lower costs and enhance supply security.

• Product Differentiation:
  Rising demand for specialty citric acid derivatives—such as those with specific antioxidant or preservative properties—will shape the competitive landscape.

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Strategic Implications for Stakeholders

• Investors should monitor technological innovations that decrease costs and expand Urea C-13 applications, especially in real-time PCR, MRI, and PET imaging markets.

• Manufacturers in citric acid should prioritize sustainable biofermentation methods and expand into niche high-value derivatives aligned with health and wellness trends.

• Regulatory Bodies should streamline pathways for approval of novel isotope-based diagnostics and environmentally friendly citric acid products, fostering faster market penetration.

• Research Institutions are encouraged to collaborate with industry for advancing labeling techniques and clinical validation studies, accelerating adoption.

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Key Takeaways

• Clinical Advancement: Urea C-13 continues to demonstrate growing clinical utility in gastric diagnostics, with trials focusing on improving test efficiency and expanding applications into gastrointestinal and metabolic disorder diagnostics.

• Market Expansion: The Urea C-13 market is poised for robust growth, driven by technological progress, expanding diagnostic needs, and decreasing production costs.

• Sustained Growth: Citric acid maintains a solid growth trajectory, with shifting preferences toward bio-based and high-purity products across food, pharmaceutical, and industrial segments.

• Innovation as a Catalyst: Advances in isotope synthesis and sustainable fermentation technologies are critical to unlocking broader adoption and reducing costs.

• Regulatory Support: Clear regulatory frameworks will facilitate faster clinical adoption of isotope-based diagnostics and eco-friendly citric acid formulations.

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Frequently Asked Questions (FAQs)

1. What are the key clinical applications of Urea C-13?
   Urea C-13 is primarily used in non-invasive breath tests for diagnosing Helicobacter pylori infections, testing gastric motility, and in metabolic and gastrointestinal research.

2. How does the cost of Urea C-13 impact its clinical adoption?
   Manufacturing costs influence pricing and accessibility. Ongoing innovations in synthesis aim to reduce expenses, thereby expanding global clinical application.

3. What factors are driving the demand for citric acid?
   Increasing use in food and beverage preservation, pharmaceutical formulations, cleaning products, and cosmetics, along with a trend toward natural and sustainable ingredients, fuel demand.

4. Are there environmentally sustainable methods for producing citric acid?
   Yes. Bio-based fermentation using renewable raw materials is increasingly becoming the preferred method due to its lower environmental impact compared to synthetic production.

5. What are the future prospects of isotope-labeled compounds in medical diagnostics?
   They are expected to become integral to precision medicine, enabling non-invasive, highly specific diagnostics, thereby expanding their clinical and commercial markets.

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References

1. ClinicalTrials.gov. "Urea C-13 in Gastric Diagnostics." [URL]
2. MarketWatch. "Global Citric Acid Market Size & Growth." [URL]
3. Isotope Business News. "Advances in Urea C-13 Synthesis Technologies." [URL]
4. Food Chemical News. "Trends in Citric Acid Production and Sustainability." [URL]
5. Allied Market Research. "Diagnostic Imaging Market Insights." [URL]

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Disclaimer: The projected market data are based on current trends, market analyses, and emerging research. Actual future market performance may vary due to unforeseen technological, regulatory, or economic factors.