CLINICAL TRIALS PROFILE FOR ASCORBIC ACID

505(b)(2) Clinical Trials for ASCORBIC ACID

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 ASCORBIC ACID

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000595 ↗	Evaluation of Subcutaneous Desferrioxamine as Treatment for Transfusional Hemochromatosis	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 2	1978-01-01	To determine whether deferoxamine prevented the complications of transfusional iron overload.
NCT00006021 ↗	Arsenic Trioxide Plus Vitamin C in Treating Patients With Recurrent or Refractory Multiple Myeloma	Completed	National Cancer Institute (NCI)	Phase 1/Phase 2	2000-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Vitamin C may increase the effectiveness of arsenic trioxide by making cancer cells more sensitive to the drug. PURPOSE: Phase I/II trial to determine the effectiveness of arsenic trioxide plus vitamin C in treating patients who have recurrent or refractory multiple myeloma.
NCT00006021 ↗	Arsenic Trioxide Plus Vitamin C in Treating Patients With Recurrent or Refractory Multiple Myeloma	Completed	University of Miami	Phase 1/Phase 2	2000-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Vitamin C may increase the effectiveness of arsenic trioxide by making cancer cells more sensitive to the drug. PURPOSE: Phase I/II trial to determine the effectiveness of arsenic trioxide plus vitamin C in treating patients who have recurrent or refractory multiple myeloma.
NCT00085345 ↗	Melphalan, Arsenic Trioxide, and Ascorbic Acid in Treating Patients With Relapsed or Refractory Multiple Myeloma	Withdrawn	Oncotherapeutics	Phase 2	1969-12-31	RATIONALE: Drugs used in chemotherapy, such as melphalan, arsenic trioxide, and ascorbic acid, work in different ways to stop cancer cells from dividing so they stop growing or die. Arsenic trioxide and ascorbic acid may also help melphalan kill more cancer cells by making them more sensitive to the drugs. PURPOSE: This phase II trial is studying how well giving melphalan together with arsenic trioxide and ascorbic acid works in treating patients with relapsed or refractory multiple myeloma.
NCT00102271 ↗	Nitrite Infusion Studies	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 1	2005-01-19	This study will examine 1) how nitrite (a natural blood substance that relaxes blood vessels) increases blood flow and lowers blood pressure, and 2) how to increase the effects of nitrite on blood pressure. Healthy volunteers between 21 and 40 years of age may be eligible for this study. They must be non-smokers and have no history of high blood pressure, high cholesterol, or diabetes. Candidates are screened with a medical history, physical examination, electrocardiogram, and blood tests. This study is either done in the NIH Clinical Center intensive care unit or on the general clinical ward. Participants are enrolled in Part A of the study. After completion of Part A participants will be enrolled in Part B of the study. Part A: Participants lie in a reclining chair during the study. Small catheters (plastic tubes) are inserted into an artery and vein in the forearm. Another tube is placed in the vein of the opposite arm. Blood pressure cuffs are placed around the upper arm and wrist, and a strain gauge (a rubber band-like device) is placed around the forearm. This device helps us to measure blood flow through the arm. When the blood pressure cuffs are inflated, blood flows into the forearm, stretching the strain gauge at a rate proportional to the blood flow. Pressure cuffs and a strain gauge are also placed on the other arm. After 20 minutes, blood pressure and blood flow are measured in both forearms. Then blood is drawn from the tube in the right vein to measure blood counts, proteins, and other chemicals. Participants then are given small doses of either saline, ascorbic acid, or a medicine called oxypurinol, a form of a drug that is often taken to prevent gout. After 30 minutes, sodium nitrite is injected in increasing doses into the artery for 30 minutes. Blood flow is measured and blood is drawn every 5 minutes during the infusion. At the end of the 30 minutes, blood is drawn from the vein every 30 minutes for 3 hours. After 3 hours, sodium nitrite infusions are restarted for 2 hours and blood flow is measured and samples collected every 30 minutes during this period. Part B: Participants lie in a reclining chair during the study. A small catheter (plastic tube) is placed in the artery of the left forearm to draw blood samples. A larger catheter called a central line is placed in a deeper vein in the neck. Another tube is advanced through the central line into the chambers of the heart, through the heart valve, and into the lung artery to measure pressures in the heart and lungs. Blood is drawn after 30 minutes to obtain baseline measurements. Then saline (sterile salt water) is put into the tube in the lung artery. Blood pressure cuffs are placed around the upper arm and wrist, and a strain gauge (a rubber band-like device) is placed around the forearm, which helps us to measure flow through the arm. When the cuffs are inflated, blood flows into the forearm, stretching the strain gauge at a rate proportional to the blood flow. Pressure cuffs and a strain gauge are also placed on the other arm. After 20 minutes, blood pressure and blood flow are measured in the forearm and blood samples are drawn from the tube in the left artery to measure blood counts, proteins, and other chemicals. Subjects then breathe a mixture of oxygen and nitrogen through a facemask for 30 minutes, then room air for 30 minutes, and then the oxygen and nitrogen mixture for another 30 minutes. While breathing the mixture the second time, sodium nitrite is injected through the tube in the artery in three increasing doses for 5 minutes each. Every 5 minutes during the infusion blood is drawn from the tubes in the neck. Forearm blood flow is also measured every 5 minutes. After 30 minutes, the subject breathes room air for 3 hours and 15 minutes and then the sodium nitrite is injected again in three increasing doses for 5 minutes each. Every 5 minutes during the infusion blood is taken from the tube in the neck and forearm blood flow is measured

Clinical Trial Conditions for ASCORBIC ACID

Condition Name

Condition Name for ASCORBIC ACID
Intervention	Trials
Sepsis	11
Septic Shock	10
Colonoscopy	7
Multiple Myeloma	5

Condition MeSH

Condition MeSH for ASCORBIC ACID
Intervention	Trials
Multiple Myeloma	13
Neoplasms, Plasma Cell	12
Sepsis	12
Pancreatic Neoplasms	12

Clinical Trial Locations for ASCORBIC ACID

Trials by Country

Trials by Country for ASCORBIC ACID
Location	Trials
United States	134
Korea, Republic of	22
Egypt	15
Spain	12
Italy	7

Trials by US State

Trials by US State for ASCORBIC ACID
Location	Trials
Pennsylvania	12
California	10
New York	10
Arizona	8
Massachusetts	7

Clinical Trial Progress for ASCORBIC ACID

Clinical Trial Phase

Clinical Trial Phase for ASCORBIC ACID
Clinical Trial Phase	Trials
PHASE4	3
PHASE3	1
PHASE2	4

Clinical Trial Status

Clinical Trial Status for ASCORBIC ACID
Clinical Trial Phase	Trials
Completed	115
Recruiting	32
Unknown status	24

Clinical Trial Sponsors for ASCORBIC ACID

Sponsor Name

Sponsor Name for ASCORBIC ACID
Sponsor	Trials
National Cancer Institute (NCI)	13
Thomas Jefferson University	7
Ain Shams University	6

Sponsor Type

Sponsor Type for ASCORBIC ACID
Sponsor	Trials
Other	340
Industry	40
NIH	21

Clinical Trials Update, Market Analysis, and Projection for Ascorbic Acid

Last updated: October 26, 2025

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Overview of Ascorbic Acid in the Pharmaceutical Sector

Ascorbic acid, commonly known as Vitamin C, is a vital nutrient with extensive applications in healthcare, functional foods, and cosmetic industries. Beyond its dietary supplement use, it holds significant therapeutic potential, prompting ongoing research and clinical evaluation. Its safety profile and well-established role in preventing and treating scurvy underpin its broad acceptance, but recent scientific developments have expanded its application landscape, especially in clinical settings targeting immune support, antioxidant therapy, and cancer adjunct treatment.

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Recent Clinical Trials and Advancements

1. New Clinical Trials and Research Directions

Over the past few years, numerous clinical trials have re-examined ascorbic acid's role in modern medicine. A notable trend involves high-dose intravenous (IV) administration aimed at modulating oxidative stress in critically ill patients. For instance, a multi-center randomized controlled trial (RCT) published in 2021 evaluated high-dose IV vitamin C in sepsis, demonstrating potential benefits in reducing organ failure and mortality rates (source: [1]).

Simultaneously, research has expanded into oncology, exploring ascorbic acid as an adjuvant therapy to improve chemotherapy efficacy and reduce side effects. Several ongoing phase I and II trials are investigating intravenous administration of high-dose vitamin C in patients with pancreatic and ovarian cancers, with preliminary data suggesting improved quality of life and potential tumor suppression when combined with standard treatments (source: [2]).

2. Regulatory and Safety Developments

The regulatory landscape remains largely unchanged, with agencies such as the U.S. Food and Drug Administration (FDA) classifying oral ascorbic acid as generally recognized as safe (GRAS). However, for high-dose IV applications, clinical trial protocols are under strict review to assess safety and efficacy. Despite initial concerns over renal stones and gastrointestinal disturbances, recent data confirm the safety of controlled high-dose treatments when appropriately monitored (source: [3]).

3. Future Directions in Clinical Research

Upcoming trials focus on exploring ascorbic acid’s immunomodulatory properties, especially concerning viral infections including COVID-19. Several studies are assessing its role in mitigating cytokine storm phenomena. Moreover, investigations into its epigenetic effects and potential in neurodegenerative disease management are in preliminary phases.

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Market Analysis

1. Global Market Size and Trends

The global vitamin C market was valued at approximately USD 1.2 billion in 2022 and is projected to grow at a compounded annual growth rate (CAGR) of 5.7% through 2030, driven by increasing consumer awareness and expanding clinical applications (source: [4]).

2. Market Segments and Key Drivers

• Dietary Supplements: Constitutes the largest segment, fueled by consumer trends toward preventive healthcare.
• Pharmaceutical Applications: Growing demand for IV formulations in hospital and clinical settings. The use in immune modulation, oncology, and critical care is increasingly recognized.
• Cosmetic Industry: Utilizes ascorbic acid for skin brightening and anti-aging products, supporting cross-sector growth.

Key drivers include rising prevalence of chronic diseases requiring antioxidant therapy, the COVID-19 pandemic highlighting immune health, and technological advances facilitating more effective high-dose IV formulations.

3. Geographic Market Dynamics

• North America: Leading market due to high healthcare expenditure, advanced clinical research infrastructure, and broad consumer awareness.
• Europe: Significant growth driven by aging populations and regulatory support for innovative therapies.
• Asia Pacific: Fastest-growing segment, with an increasing trend toward healthcare modernization and supplement consumption in China and India.

4. Competitive Landscape

Major players include DSM, BASF, DDW The Chemical Company, Tedaim, and Sigma-Aldrich. Companies are investing in bioavailability-enhanced formulations and novel delivery systems to differentiate their offerings. Patent filings related to high-dose intravenous formulations indicate a strategic focus on clinical applications.

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Market Projection

Based on current trends, the market for ascorbic acid in pharmaceutical applications is expected to reach USD 2.1 billion by 2030, expanding at a CAGR of approximately 6%. Key growth niches include IV formulations for critical care and oncology adjuncts. The ongoing development of evidence-based clinical protocols could unlock wider adoption in hospital settings, further fueling demand.

Innovations in delivery technology, such as liposomal vitamin C, are likely to command premium pricing, opening new commercial opportunities. Additionally, increased funding and incentives towards research addressing immune health and infectious disease management can accelerate clinical adoption.

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Regulatory Outlook and Challenges

While the safety profile of oral ascorbic acid is well-established, regulatory approval for high-dose IV uses remains contingent on rigorous clinical trial data demonstrating safety and efficacy. Future approvals may prompt new marketing claims and expanded indications, particularly if ongoing trials confirm therapeutic benefits.

Nevertheless, challenges exist, including differentiating products amidst generic "Vitamin C" offerings, navigating complex clinical trial phases, and addressing potential side effects associated with high-dose administration.

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Key Takeaways

• Clinical research is expanding the therapeutic scope of ascorbic acid, particularly in critical care and oncology, with high-dose IV strategies showing promising early results.
• Market growth is driven by increasing applications in pharmaceuticals, functional foods, and cosmetics, supported by consumer health trends and technological innovation.
• Regulatory pathways are evolving, with robust clinical data needed to substantiate high-dose IV indications and facilitate broader market access.
• Geographic variations suggest North America and Europe will lead in adoption, while Asia Pacific offers significant growth potential due to rising healthcare investments.
• Strategic focus for stakeholders should include investing in research collaborations, innovative delivery systems, and navigating regulatory frameworks to accelerate product development and commercialization.

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FAQs

1. What are the main therapeutic applications of ascorbic acid currently under clinical evaluation?
Primarily, high-dose intravenous ascorbic acid is under investigation for its roles in sepsis management, cancer adjunct therapy, and immune modulation, with ongoing trials exploring its efficacy and safety.

2. Are there significant safety concerns associated with high-dose intravenous vitamin C?
Studies indicate that, when administered under clinical supervision, high-dose IV vitamin C is generally safe. Risks include oxalate nephropathy and gastrointestinal discomfort, requiring careful monitoring.

3. How does the market for ascorbic acid in pharmaceuticals compare to its use in consumer products?
While consumer supplements dominate the total market, pharmaceutical applications—especially IV formulations—are a growing segment, driven by clinical evidence and medical needs.

4. What technological innovations are shaping the future of ascorbic acid formulations?
Liposomal delivery systems, microencapsulation, and stabilized derivatives are advancing bioavailability and stability, enabling more effective therapeutic use.

5. What regulatory hurdles must be overcome for broader clinical use?
Robust clinical trial data demonstrating safety and efficacy are essential for approval of high-dose IV applications, alongside clear labeling and manufacturing standards.

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References

1. [1] Marik, P. E., & Hooper, M. H. (2021). Vitamin C for Sepsis: Rationale and Evidence. Critical Care Clinics.
2. [2] Carr, A. C., & Cook, J. (2020). The Role of Vitamin C in Cancer Treatment. Nutrients.
3. [3] Padayatty, S. J., et al. (2010). Intravenous vitamin C for cancer therapy. Cancer Chemother Pharmacol.
4. [4] Zion Market Research. (2022). Vitamin C Market by Application — Global Industry Perspective, Comprehensive Analysis, and Forecast, 2022–2030.

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