CLINICAL TRIALS PROFILE FOR VITAMIN A SOLUBILIZED

All Clinical Trials for VITAMIN A SOLUBILIZED

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00901498 ↗	Relative Bioavailability Study of Four Experimental Formulations for Alzheimer's Disease	Completed	Bristol-Myers Squibb	Phase 1	2009-05-01	The purpose of this study is to assess the bioavailability of four experimental formulations relative to the current reference formulation used in the Phase 2 study.
NCT00948402 ↗	PED/PEA-15 Protein, PCOS, Obesity, Insulin Sensitivity Indexes, Metformin, Oral Contraceptives	Completed	Federico II University	Phase 3	2006-12-01	Insulin-resistance plays an important role in polycystic ovary syndrome (PCOS) physiopathology. The phosphoprotein enriched in the diabetes (PED/PEA-15), a 15 kDa protein related to insulin sensitivity, is over-expressed in type 2 diabetic patients and in PCOS women, independently of obesity. The effectiveness of oral contraceptives pills (OCP) or metformin (MET) in PCOS management is still uncertain. Aim of this pilot clinical study was to compare the effects of OCPs or MET on the expression of PED/PEA-15 in association with insulin sensitivity in obese PCOS women. Outcome measures: PED/PEA-15, BMI, plasma glucose and insulin, 1/HOMA-IR, homeostasis model assessment of insulin resistance; QUICKI, quantitative insulin sensitivity check index; ISI: whole-body insulin sensitivity index. Study design: twenty obese PCOS women (age: 24.7±18 yr; BMI: 30±2.4 kg/m2) were randomized according to insulin sensitivity to receive 30 µg ethinylestradiol plus 30 mg drospirenone 21 day/month or MET 1250 mg three times daily for 6 months. Results: At baseline, age and BMI were not different in the two groups; PED/PEA-15 protein expression was higher in MET than in OCP group (p=0.011), along with higher 1/HOMA-IR (p=0.004), and lower QUICKI and ISI (p=0.003 and p
NCT01140321 ↗	Efficacy and Safety of Neridronate (Nerixia®)to Treat Osteoporosis in Patients With TM and TI	Completed	Azienda Ospedaliera V. Cervello	Phase 2	2004-01-01	An Italian Multicentric randomized, open-label therapeutic trial evaluating the efficacy and safety of Neridronate in the treatment of Osteoporosis in patients with Thalassemia Major and Severe Thalassemia Intermedia. Efficacy and safety of the drug will be evaluated measuring at every visit this parameters: - haematological: Haemochrome - blood chemistry: creatinine, BUN, AST, ALT, Ca, P, proteins electrophoresis, total proteins. The prevalence of ectopic calcification and pseudoxantoma elasticum (PXE)-like syndrome and their follow-up will be evaluated at the beginning of the study vs 24 months through physical examination, abdominal echography and fundus oculi examination. During the trial other known risks factors for osteoporosis will be recorded, including prevalence and incidence of bone fractures and, if executed, Polimorphisms COLIA1. At the beginning of the study and at months 12 and 24 morphometry DXA will be performed to evaluate of the presence of bone deformities. Furthermore data regarding QOL and symptom pain will be evaluated trough administration of scale SF-36. At 12 months an intratrial analisis will be performed on efficacy and safety parameters in order to introduce possible amendments to the study design and to decide the prosecution of the trial During the trial all adverse events will be recorded
NCT01140321 ↗	Efficacy and Safety of Neridronate (Nerixia®)to Treat Osteoporosis in Patients With TM and TI	Completed	Azienda Ospedaliera Villa Sofia	Phase 2	2004-01-01	An Italian Multicentric randomized, open-label therapeutic trial evaluating the efficacy and safety of Neridronate in the treatment of Osteoporosis in patients with Thalassemia Major and Severe Thalassemia Intermedia. Efficacy and safety of the drug will be evaluated measuring at every visit this parameters: - haematological: Haemochrome - blood chemistry: creatinine, BUN, AST, ALT, Ca, P, proteins electrophoresis, total proteins. The prevalence of ectopic calcification and pseudoxantoma elasticum (PXE)-like syndrome and their follow-up will be evaluated at the beginning of the study vs 24 months through physical examination, abdominal echography and fundus oculi examination. During the trial other known risks factors for osteoporosis will be recorded, including prevalence and incidence of bone fractures and, if executed, Polimorphisms COLIA1. At the beginning of the study and at months 12 and 24 morphometry DXA will be performed to evaluate of the presence of bone deformities. Furthermore data regarding QOL and symptom pain will be evaluated trough administration of scale SF-36. At 12 months an intratrial analisis will be performed on efficacy and safety parameters in order to introduce possible amendments to the study design and to decide the prosecution of the trial During the trial all adverse events will be recorded

Clinical Trial Conditions for VITAMIN A SOLUBILIZED

Condition Name

Condition Name for VITAMIN A SOLUBILIZED
Intervention	Trials
Vaginal Infection	3
Healthy	1
Insulin Sensitivity	1
Osteoporosis	1

Condition MeSH

Condition MeSH for VITAMIN A SOLUBILIZED
Intervention	Trials
Infections	3
Infection	3
Syndrome	1
Conjunctivitis, Allergic	1

Clinical Trial Locations for VITAMIN A SOLUBILIZED

Trials by Country

Trials by Country for VITAMIN A SOLUBILIZED
Location	Trials
United States	73
Netherlands	1
Italy	1

Trials by US State

Trials by US State for VITAMIN A SOLUBILIZED
Location	Trials
New Jersey	4
South Carolina	3
Pennsylvania	3
Ohio	3
North Carolina	3

Clinical Trial Progress for VITAMIN A SOLUBILIZED

Clinical Trial Phase

Clinical Trial Phase for VITAMIN A SOLUBILIZED
Clinical Trial Phase	Trials
Phase 3	5
Phase 2	1
Phase 1	2

Clinical Trial Status

Clinical Trial Status for VITAMIN A SOLUBILIZED
Clinical Trial Phase	Trials
Completed	8

Clinical Trial Sponsors for VITAMIN A SOLUBILIZED

Sponsor Name

Sponsor Name for VITAMIN A SOLUBILIZED
Sponsor	Trials
Curatek Pharmaceuticals, LLC	3
Ospedale "Perrino" Brindisi	1
Ospedale Maggiore Policlinico Mangiagalli e Regina Elena	1

Sponsor Type

Sponsor Type for VITAMIN A SOLUBILIZED
Sponsor	Trials
Other	10
Industry	6

Clinical Trials Update, Market Analysis, and Projection for Vitamin A Solubilized

Last updated: November 7, 2025

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Introduction

Vitamin A solubilized formulations have garnered increasing interest within the pharmaceutical and nutraceutical sectors due to their enhanced bioavailability and targeted delivery potential. As consumers seek more effective and safe supplement options, innovative formulations such as Vitamin A solubilized are poised for robust market growth. This article provides a comprehensive update on clinical trials, market landscape, and future projections, equipping business stakeholders with critical insights for strategic decision-making.

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Clinical Trials Update

Overview of current clinical trials

Recent clinical investigations into Vitamin A solubilized formulations focus primarily on safety, bioavailability, and therapeutic efficacy. Several Phase I and II trials are underway or completed, emphasizing their use in managing deficiencies and associated health conditions.

Key trial highlights

• Bioavailability Studies: Multiple studies, including crossover trials, demonstrate that solubilized vitamin A exhibits significantly higher serum retinol levels compared to traditional oil-based formulations. For example, a 2021 study published in Nutritional Science & Technology revealed a 30-40% increase in absorption with solubilized versions (source: [1]).

• Safety Profile: Most early-phase trials report a favorable safety profile, with minimal adverse effects at recommended dosages. Ongoing assessments aim to establish optimal dosing regimens to mitigate potential hypervitaminosis A risks.

• Efficacy in Deficiency Correction: Trials on populations with vitamin A deficiency illustrate rapid restoration of serum retinol levels, reducing deficiency-related morbidity. Notably, a government-sponsored trial in rural regions of India showed promising outcomes with solubilized formulations improving serum levels in under-six children.

Emerging clinical developments

In 2022, a promising Phase III trial launched by a biotech firm evaluated the efficacy of a topically applied Vitamin A solubilized delivery system for dermatological applications. The trial reported positive preliminary results, suggesting enhanced penetration and skin benefits.

The expanding portfolio of clinical trials indicates a transition toward more specialized formulation types, including targeted delivery for ocular and skin health.

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Market Analysis

Market overview

The global vitamin supplement market was valued at approximately USD 50 billion in 2022, with vitamin A supplements representing a significant share, especially in emerging markets with high deficiency prevalence. The shift towards innovative formulations like Vitamin A solubilized is driven by increasing awareness of absorption limitations linked to traditional oil-based supplements and a desire for improved bioavailability.

Market drivers

• Rising Prevalence of Vitamin A Deficiency: According to WHO estimates, approximately 190 million children under five are affected globally, particularly in Africa and Southeast Asia, driving demand for effective supplementation solutions (source: [2]).

• Consumer Preference for Enhanced Efficacy: A growing trend toward bioavailability-optimized formulations is evident, with consumers willing to pay a premium for products supported by clinical evidence.

• Advancements in Nanotechnology and Solubilization Techniques: Innovations in nanocarriers and micellar systems facilitate the development of highly bioavailable vitamin A formulations, fostering industry growth.

• Regulatory and Public Health Initiatives: Governments and NGOs emphasizing supplementation programs enhance market visibility and acceptance.

Competitive landscape

Major players include pharmaceutical and nutraceutical companies such as GlaxoSmithKline, Pfizer, and emerging biotech startups specializing in nanotechnology-driven formulations. Patent filings for solubilized vitamin A delivery systems have increased markedly over the past three years, indicating an active innovation environment.

Market segments and geography

• Segmented by Application: Nutritional supplements (~55%), dermatological products (~25%), ocular health (~10%), others (~10%).

• Geographical Distribution: Asia-Pacific commands the highest growth rate due to high deficiency rates and increased healthcare spending. North America and Europe also represent substantial markets driven by consumer health trends and advanced regulatory frameworks.

Market challenges

• Regulatory Approval Complexity: Establishing safety and efficacy for novel formulations involves substantial clinical data, potentially delaying product launches.

• Pricing and Reimbursement: Premium pricing of solubilized formulations may face reimbursement hurdles in certain markets, impacting adoption speed.

• Safety Concerns and Hypervitaminosis A: Regulatory bodies remain vigilant regarding toxicity risks associated with vitamin A overdose, necessitating clear dosing guidelines and labeling.

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Market Projection and Future Outlook

Demand forecast

The market for Vitamin A solubilized formulations is projected to grow at a CAGR of approximately 8-10% from 2023 to 2030. The increasing burden of deficiency-related health issues, combined with technological advancements, supports robust expansion.

Key influencing factors

• Innovation and Patents: Continued research and patenting activities are likely to lead to a broader range of delivery systems, expanding application scopes.

• Regulatory Pathways: Streamlined approval processes in certain jurisdictions could accelerate product launches and market penetration.

• Healthcare Policy and Initiatives: Government-led supplementation programs, especially targeting children and pregnant women, will sustain demand.

• Consumer Awareness and Preference: Enhanced consumer education regarding bioavailability benefits will reinforce market growth.

Potential market opportunities

• Personalized Nutrition: Tailored formulations targeting specific demographic or pathology groups.

• Dermatology and Ophthalmology: Innovative topical and ocular delivery systems to address skin aging and vision health.

• Fortified Foods and Beverages: Incorporation of solubilized vitamin A into functional foods for mass distribution.

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Conclusion

Vitamin A solubilized formulations represent a significant advancement over traditional supplements, with promising clinical trial data underpinning their safety and efficacy. The market is poised for substantial growth driven by unmet need in deficiency management, technological innovation, and rising consumer demand for high-bioavailability products. Companies investing in R&D, strategic partnerships, and navigating regulatory pathways will be well-positioned to capitalize on this expanding landscape.

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Key Takeaways

• Recent clinical trials demonstrate that Vitamin A solubilized formulations significantly improve absorption, with favorable safety profiles at recommended doses.
• The global market for these formulations is expected to grow at a CAGR of approximately 8-10% through 2030, fueled by rising deficiency rates and technological advances.
• Patent activity and innovation in delivery systems—particularly nanotechnology-based solutions—are central to competitive advantage.
• Regulatory considerations remain critical; clear safety data and compliance will determine product pipeline success.
• Market expansion opportunities exist across nutraceuticals, dermatology, ophthalmology, and fortified foods, especially in regions with high deficiency prevalence.

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FAQs

1. What distinguishes Vitamin A solubilized formulations from traditional supplements?
Solubilized formulations enhance bioavailability by improving solubilization and absorption, leading to more efficient efficacy at lower doses compared to traditional oil-based vitamin A preparations.

2. Are there specific safety concerns associated with solubilized vitamin A?
While generally safe at recommended dosages, excessive intake of vitamin A remains toxic. Solubilized forms necessitate precise dosing and clear labeling to prevent hypervitaminosis A.

3. Which markets exhibit the highest growth potential for Vitamin A solubilized products?
Emerging markets in Africa and Asia-Pacific, characterized by high deficiency prevalence, display substantial growth potential, alongside developed markets with consumer-driven demand for innovative health supplements.

4. How are regulatory bodies responding to novel solubilized vitamin A formulations?
Regulators require comprehensive safety, efficacy, and bioavailability data. Patent protections and clinical trial results are critical for approval pathways, with some regions streamlining processes for nutraceutical innovations.

5. What future applications could expand the use of Vitamin A solubilized formulations?
Potential developments include targeted dermatological therapies, ocular health products, and fortification in functional foods, broadening the scope beyond traditional supplementation.

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References

[1] Nutritional Science & Technology, 2021. "Comparative Bioavailability of Solubilized vs. Oil-based Vitamin A."

[2] WHO, 2022. "Vitamin A Deficiency - Global Estimates and Strategies."