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
NCT01140321 ↗	Efficacy and Safety of Neridronate (Nerixia®)to Treat Osteoporosis in Patients With TM and TI	Completed	Ospedale "Perrino" Brindisi	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	Ospedale Maggiore Policlinico Mangiagalli e Regina Elena	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	Reggio Calabria	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
Alzheimer's Disease	1
Healthy	1
Insulin Sensitivity	1

Condition MeSH

Condition MeSH for Vitamin A Solubilized
Intervention	Trials
Infections	3
Infection	3
beta-Thalassemia	1
Syndrome	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
Washington	3
Texas	3
Tennessee	3
South 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
Federico II University	1
Alcon Research	1

Sponsor Type

Sponsor Type for Vitamin A Solubilized
Sponsor	Trials
Other	10
Industry	6

Last updated: May 9, 2026

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

What is “Vitamin A Solubilized” in the commercial and regulatory context?

“Vitamin A solubilized” is a marketed form of vitamin A designed to improve dispersion and/or bioavailability versus oil-based or less soluble vitamin A ingredients. The term is typically used in product labeling to differentiate a solubilized formulation from conventional vitamin A (often retinyl palmitate in oils) used in nutritional supplements, clinical nutrition, or fortification programs.

In patents and product listings, “solubilized vitamin A” most commonly aligns with:

• Water-dispersible or emulsified vitamin A systems
• Complexed or carrier-based vitamin A forms intended to improve stability and delivery in aqueous media

Because “Vitamin A solubilized” is a formulation descriptor rather than a single active ingredient salt, the clinical and patent landscape depends on the exact formulation, carrier, and intended use (supplement vs. parenteral vs. enteral nutrition).

Which clinical trials exist for Vitamin A solubilized?

No complete, product-specific clinical-trial set for “Vitamin A solubilized” is available from the sources required for a complete update (trial IDs, sponsors, endpoints, and dates) within the constraints of this task. As a result, a precise, evidence-backed “clinical trials update” cannot be produced without risking factual gaps.

What markets does Vitamin A solubilized address?

Vitamin A is a global ingredient used across:

• Dietary supplements and fortified foods (preventive and deficiency-driven demand)
• Clinical nutrition (enteral and parenteral workflows where formulation solubility matters)
• Therapeutic nutrition programs (maternal and pediatric health, malnutrition interventions)

The solubilized form is a formulation-choice lever in products where:

• water miscibility or dispersion affects manufacturing and dosing accuracy
• stability over shelf-life impacts procurement and compliance
• delivery targets improve tolerance in aqueous matrices

Market sizing approach (formulation-dependent)

A robust market forecast requires mapping “Vitamin A solubilized” to:

• the active (retinol/retinyl palmitate/retinyl acetate or other vitamin A forms)
• the use case (supplement vs. medical nutrition)
• the region and channel (pharmacy, hospital procurement, retail)

This task does not provide the input mapping required to isolate “Vitamin A solubilized” from the much larger vitamin A market. Without that mapping, any numerical projection would risk being non-factual.

Where does value accrue in solubilized vitamin A?

Commercial value generally concentrates in the formulation IP and supply chain around:

• manufacturing process (stability, particle size or dispersion, emulsification)
• regulatory support (stability and bioavailability package for the exact formulation)
• claims (solubility, dispersion, tolerability, and performance in aqueous dosing systems)

For investors and R&D teams, the actionable question is not “vitamin A demand,” but “does the solubilized form enable premium pricing or formulary inclusion in medical nutrition?”

Regulatory and labeling dynamics

Vitamin A is widely regulated as:

• a nutrient ingredient in supplements and foods (with potency labeling constraints)
• an essential vitamin in medical nutrition products (with strict compositional and stability controls)

For solubilized variants, the regulatory differentiation is tied to:

• formulation stability in target matrices
• shelf-life and handling conditions
• tolerability and bioavailability evidence for the specific carrier system

Competitive landscape (format-risk)

Because “Vitamin A solubilized” can denote multiple technical solutions, the competitive set can include:

• major vitamin ingredient suppliers offering water-dispersible or emulsified vitamin A premixes
• medical nutrition ingredient providers supplying hospital-grade nutrition emulsions and micronutrient systems
• regional nutrition supplement manufacturers using proprietary solubilized systems

A product-level competitive map requires the exact brand/tradename, INCI/ingredient declaration, or supplier specification. This task does not include those identifiers.

Investment and R&D projection logic (how to underwrite Vitamin A solubilized)

A defensible projection model for a solubilized vitamin A product typically uses four drivers:

1. Volume replacement: incremental share captured from conventional vitamin A forms in aqueous products
2. Pricing premium: margin lift from improved formulation performance
3. Regulatory friction: cost and time to maintain approvals across geographies and intended-use claims
4. Stability economics: cost of goods impact from shelf-life and packaging requirements

A complete projection depends on inputs not provided in this task.

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Clinical development prospects: what endpoints matter and why

Even without a trial catalog, the development standard for solubilized fat-soluble micronutrients centers on:

• bioavailability (serum retinol or retinyl ester response in the target population)
• tolerability (GI tolerance in oral and enteral settings)
• stability (potency retention over time in the final matrix)
• delivery performance (dispersion, homogeneity, dosing accuracy)

For a new solubilized vitamin A entrant, the commercialization bottleneck usually comes from:

• the stability package for the exact formulation in the final finished product
• clinical or bridging evidence supporting the intended claim

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Key Takeaways

• “Vitamin A solubilized” is a formulation descriptor; market and clinical evidence are formulation-specific, not ingredient-agnostic.
• A complete, product-specific clinical trials update with trial-level facts cannot be generated from the required source inputs in this task.
• Market forecasting requires mapping “Vitamin A solubilized” to exact active form, carrier system, and intended use to isolate demand and channel economics.
• Underwriting should focus on bioavailability evidence, stability economics, tolerability, and whether the solubilized format earns premium share in aqueous supplement or medical nutrition channels.

FAQs

1. Is “Vitamin A solubilized” a specific molecule or a formulation approach?
   It is primarily a formulation approach applied to vitamin A forms to improve dispersion or bioavailability in aqueous dosing contexts.

2. Why can’t clinical trials be summarized at the “Vitamin A solubilized” label level?
   Trial outcomes and endpoints attach to the exact formulation and carrier, not the generic descriptor.

3. What does market demand depend on for solubilized vitamin A?
   It depends on the downstream product category (supplement vs. clinical nutrition), the dosing matrix, and whether manufacturers can claim performance and stability advantages.

4. What clinical endpoints typically support solubilized vitamin A positioning?
   Serum retinol or related vitamin A biomarkers, tolerability, and stability-linked performance in the intended matrix.

5. What drives pricing power for solubilized vitamin A products?
   Premium claims tied to delivery (bioavailability/dispersion) and reduced manufacturing or compliance costs due to stability and dosing uniformity.

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References

[1] No sources were provided in the task to support a factual clinical trials update or a quantified market projection for “Vitamin A solubilized.”