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<0.001, respectively). After treatment, independently of body weight, only in MET group PED/PEA-15 decreased (p=0.004), along with insulin and 1/HOMA-IR (p<0.001), and QUICKI and ISI increased (p<0.001). Insulin sensitivity indexes improvement correlated significantly with PED/PEA-15 protein expression, but not with BMI. Conclusions: PED/PEA-15 protein over-expression in obese PCOS women with IR reduced after a six month treatment with MET, while remained unchanged in the OCP group. The reduction was independent of body weight, and correlated with insulin sensitivity indexes. This effect further supported MET as a more effective therapy than OCPs for obese PCOS women with IR, also when fertility is not required.
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
Osteoporosis	1
Polycystic Ovarian Syndrome	1
Thalassemia Intermedia	1

Condition MeSH

Condition MeSH for Vitamin A Solubilized
Intervention	Trials
Infections	3
Infection	3
Thalassemia	1
Alzheimer Disease	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
Arkansas	3
Arizona	3
Alabama	3
Washington	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
Ente Ospedaliero Ospedali Galliera	1
Bristol-Myers Squibb	1

Sponsor Type

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

Vitamin A Solubilized: Clinical Trials, Market Analysis, and Projections

Introduction to Vitamin A

Vitamin A, a fat-soluble vitamin, is crucial for various bodily functions, including vision, immune system function, and skin health. It exists in several forms, such as retinol, retinal, and retinoic acid, and can be obtained from both animal and plant sources[1].

Clinical Trials and Efficacy of Vitamin A

Overview of Clinical Trials

Clinical trials have extensively evaluated the effects of vitamin A supplementation on various health outcomes. Here are some key findings:

• Mortality and Health Outcomes: A systematic review of randomized clinical trials found that vitamin A supplementation did not significantly reduce mortality in individually randomized trials. However, cluster randomized trials suggested a beneficial effect on mortality, although the evidence was of very low certainty[3].
• Viral Infections: Studies have examined the impact of vitamin A on viral infections, particularly in HIV-infected individuals. While some trials showed no significant difference in HIV-1 plasma viral load or overall morbidity, others indicated benefits such as reduced incidence of preterm births and lower diarrhea incidence[4].
• Adverse Effects: Vitamin A supplementation has been associated with some adverse effects, such as an increased incidence of bulging fontanelle in neonates and infants. However, serious adverse events or impacts on quality of life were not commonly reported[3].

Specific Trials and Findings

• HIV-1 Infected Children and Women: Trials conducted in South Africa and Tanzania showed mixed results. For example, a study by Coutsoudis (1995) found a significant lower incidence of diarrhea in children receiving vitamin A supplementation, while another study by Villamor (2002) showed no significant difference in HIV-1 plasma viral load or overall morbidity[4].
• Cluster Randomized Trials: These trials, which often involve larger populations, suggested a beneficial effect of vitamin A on mortality, particularly in children. However, the certainty of this evidence is very low[3].

Market Analysis of Vitamin A

Global Market Size and Growth

The global vitamin A market has been growing steadily, driven by several factors:

• Market Size: As of 2023, the global vitamin A market was valued at approximately USD 565.18 million and is expected to grow at a CAGR of 4.81% from 2024 to 2030, reaching nearly USD 785.24 million[2].
• Regional Insights: North America currently dominates the market, holding a 39.2% market share in 2023. However, Europe is expected to grow at a faster CAGR during the forecast period due to increased health awareness and urbanization[2].

Segmentation and Applications

• Product Types: The market is segmented into food-grade, feed-grade, and pharmaceutical-grade vitamin A. The feed-grade segment holds the largest market share, accounting for 80% in 2023, due to its critical role in animal health and development[2].
• Forms: Vitamin A is available in powder and liquid forms. The powder segment is expected to grow rapidly, with a CAGR of 5.9% during the forecast period, although liquid vitamins are easier to store and transport[2].

Driving Factors

• Health Awareness and Urbanization: Increasing consumer health concerns, particularly about chronic diseases, and a growing desire for a healthier lifestyle are driving the demand for vitamin A. Urbanization and rising economic levels have also shifted consumer interest towards healthier diets[2][5].
• Animal Feed and Livestock Health: The demand for vitamin A in animal feed has increased significantly, driven by the growing need for meat and related products. This has led to an expansion in the product portfolios of leading companies in the vitamin A market[2].

Projections and Future Trends

Market Growth Projections

• CAGR and Market Size: The global vitamin A market is projected to grow at a CAGR of 4.81% from 2024 to 2030, reaching a market size of nearly USD 785.24 million by 2030[2].
• Regional Growth: Europe is expected to register the fastest revenue growth rate during the forecast period, driven by government initiatives to control vitamin A deficiency and a trend towards healthier eating[5].

Emerging Markets and Trends

• Asia Pacific: This region is expected to account for a significant revenue share due to rising living standards and increasing health consciousness among consumers. India, in particular, is a key market due to its large population and diverse consumer needs[5].
• Dietary Supplements and Skin Care: The rapid growth of the dietary supplement industry and increasing consumer spending on skin care products are key factors driving market revenue growth. Vitamin A's therapeutic applications, such as its role in anti-aging and skin health, are becoming increasingly popular[5].

Key Takeaways

• Clinical Trials: Vitamin A supplementation has mixed effects on health outcomes, with some trials showing benefits in specific contexts but overall moderate to very low certainty of evidence.
• Market Growth: The global vitamin A market is growing steadily, driven by health awareness, urbanization, and the increasing demand for animal feed and dietary supplements.
• Regional Insights: North America currently leads the market, but Europe and the Asia Pacific region are expected to show significant growth in the coming years.
• Applications and Forms: The feed-grade segment dominates the market, but the powder form of vitamin A is expected to grow rapidly.

FAQs

What are the primary forms of vitamin A?

Vitamin A exists in several forms, including retinol, retinal, and retinoic acid, as well as provitamin A carotenoids like beta-carotene[1].

How is vitamin A stored in the body?

Most of the body's vitamin A is stored in the liver in the form of retinyl esters[1].

What are the key drivers of the vitamin A market?

The market is driven by increasing health awareness, urbanization, the growing demand for animal feed, and the rise in consumer spending on dietary supplements and skin care products[2][5].

Which region is expected to grow the fastest in the vitamin A market?

Europe is expected to register the fastest revenue growth rate during the forecast period due to government initiatives and a trend towards healthier eating[5].

What are the potential adverse effects of vitamin A supplementation?

Vitamin A supplementation can lead to adverse effects such as bulging fontanelle in neonates and infants, although serious adverse events are rare[3].

Sources

1. National Institutes of Health. Vitamin A and Carotenoids - Health Professional Fact Sheet. Updated December 15, 2023.
2. Maximize Market Research. Vitamin A Market - Global Industry Analysis and Trends (2024-2030).
3. BMJ. A systematic review of randomised clinical trials with meta-analysis: The preventive effects of vitamin A supplements.
4. MDPI. What Are the Effects of Vitamin A Oral Supplementation in Viral Infections?
5. Emergen Research. Vitamin A Market Size, Trend, Demand Analysis till 2032.