CLINICAL TRIALS PROFILE FOR VITAMIN A PALMITATE

505(b)(2) Clinical Trials for VITAMIN A PALMITATE

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
OTC	NCT01451918 ↗	Regulation of Intestinal and Hepatic Lipoprotein Secretion by Resveratrol	Completed	Canadian Institutes of Health Research (CIHR)	Phase 2	2011-10-01	Resveratrol, an ingredient of red wine and available in Canada in highly purified form as an over-the-counter health supplement, has been shown to have a number of health benefits. Data from in vitro and animal studies suggest that it has beneficial effects on insulin sensitivity and lipid lowering. The investigators are not aware, however, of any mechanistic studies that have examined the effect of highly purified resveratrol in vivo on lipoprotein metabolism in humans. Given the potential therapeutic benefit of resveratrol in correcting the metabolic abnormalities of insulin resistant individuals the investigators plan to examine the effects of resveratrol on intestinal and hepatic lipoprotein production in humans.
OTC	NCT01451918 ↗	Regulation of Intestinal and Hepatic Lipoprotein Secretion by Resveratrol	Completed	University Health Network, Toronto	Phase 2	2011-10-01	Resveratrol, an ingredient of red wine and available in Canada in highly purified form as an over-the-counter health supplement, has been shown to have a number of health benefits. Data from in vitro and animal studies suggest that it has beneficial effects on insulin sensitivity and lipid lowering. The investigators are not aware, however, of any mechanistic studies that have examined the effect of highly purified resveratrol in vivo on lipoprotein metabolism in humans. Given the potential therapeutic benefit of resveratrol in correcting the metabolic abnormalities of insulin resistant individuals the investigators plan to examine the effects of resveratrol on intestinal and hepatic lipoprotein production in humans.

All Clinical Trials for VITAMIN A PALMITATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000116 ↗	Randomized Trial for Retinitis Pigmentosa	Completed	National Eye Institute (NEI)	Phase 3	1996-05-01	The purpose of this trial is to determine whether a nutritional supplement in addition to vitamin A will slow the course of retinitis pigmentosa.
NCT00001972 ↗	PET Scan of Brain Metabolism in Relation to Age and Disease	Completed	National Institute of Neurological Disorders and Stroke (NINDS)		1994-09-01	The main source of energy for the brain comes from a combination of oxygen and glucose (sugar). For brain cells to function normally they must receive a constant supply of these nutrients. As areas of the brain become more active blood flow into and out of these areas increase. In addition to oxygen and glucose, the brain uses chemical compounds known as phospholipids. These phospholipids make up the covering of nerve cells that assist in the transfer of information from cell to cell. Without phospholipids brain cell activity may become abnormal and cause problems in the nervous system. Certain diseases like Alzheimer's disease and brain tumors can affect blood flow to the brain and change the way the brain metabolizes phospholipids. In addition to diseases, changes in the brain occur with normal healthy aging. This study is designed to use PET scan to measure changes in blood flow and changes in phospholipid metabolism. Using this technique, researchers can improve their understanding of how certain diseases change the shape and function of the brain.
NCT00063596 ↗	Vitamin A Supplementation in Preterm Infants	Unknown status	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	N/A	2000-01-01	Extremely low birth weight infants have decreased blood levels of Vitamin A. This Vitamin A deficiency may increase the risk of infections and chronic lung disease in these infants. This study will examine the effects of Vitamin A supplementation in premature babies born weighing less than 1500 grams (3.3 lbs).

Clinical Trial Conditions for VITAMIN A PALMITATE

Condition Name

Condition Name for VITAMIN A PALMITATE
Intervention	Trials
Schizophrenia	51
Type 2 Diabetes	7
Obesity	5

Condition MeSH

Condition MeSH for VITAMIN A PALMITATE
Intervention	Trials
Schizophrenia	54
Diabetes Mellitus, Type 2	11
Diabetes Mellitus	9

Clinical Trial Locations for VITAMIN A PALMITATE

Trials by Country

Trials by Country for VITAMIN A PALMITATE
Location	Trials
United States	265
Canada	18
Korea, Republic of	17
China	14
Taiwan	12

Trials by US State

Trials by US State for VITAMIN A PALMITATE
Location	Trials
Texas	21
California	20
Missouri	16
Illinois	13
Florida	13

Clinical Trial Progress for VITAMIN A PALMITATE

Clinical Trial Phase

Clinical Trial Phase for VITAMIN A PALMITATE
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	24
Phase 3	30

Clinical Trial Status

Clinical Trial Status for VITAMIN A PALMITATE
Clinical Trial Phase	Trials
Completed	79
Recruiting	14
Unknown status	7

Clinical Trial Sponsors for VITAMIN A PALMITATE

Sponsor Name

Sponsor Name for VITAMIN A PALMITATE
Sponsor	Trials
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	11
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	9
Janssen Research & Development, LLC	6

Sponsor Type

Sponsor Type for VITAMIN A PALMITATE
Sponsor	Trials
Other	108
Industry	54
NIH	21

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

Last updated: October 30, 2025

---

Introduction

Vitamin A palmitate, a synthetic esterified form of vitamin A, is widely used in dietary supplements, fortified foods, cosmetics, and pharmaceutical formulations. Its stability and bioavailability make it a preferred choice over natural vitamin A sources. This article provides an analytical overview of recent clinical trials, market dynamics, and future projections surrounding vitamin A palmitate, highlighting critical industry trends, emerging research, and commercial opportunities.

---

Clinical Trials Landscape and Developments

Recent Clinical Investigations and Research Focus

In recent years, clinical research has centered on the efficacy, safety, and pharmacokinetics of vitamin A palmitate. Notably:

• Visual and Ocular Health: Several trials have evaluated its role in mitigating age-related macular degeneration (AMD) and supporting overall eye health. A 2021 randomized controlled trial published in 'Ophthalmic Epidemiology' demonstrated that vitamin A supplementation, including palmitate forms, slowed progression of AMD in high-risk populations (source [1]).

• Nutritional Supplementation: Research continues to underscore its importance among populations with vitamin A deficiency, especially in developing countries. A 2022 phase II trial assessed its bioavailability when administered via different formulations, confirming enhanced stability and absorption rates compared to natural sources (source [2]).

• Dermatological Applications: Investigations into topical applications for skin health and anti-aging properties are underway. Preliminary results suggest that vitamin A palmitate improves skin elasticity and reduces fine lines when incorporated into cosmetic formulations, but comprehensive clinical data remains limited.

Regulatory and Safety Evaluations

Regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) recognize vitamin A palmitate as Generally Recognized As Safe (GRAS) when consumed within established limits. Ongoing clinical trials aim to refine safe dosage parameters and elucidate long-term safety, especially in high-dose supplementation scenarios.

---

Market Analysis

Market Size and Segmentation

The global vitamin A market, valued at approximately USD 340 million in 2022, includes a significant proportion dedicated to vitamin A palmitate, owing to its stability and versatility [3]. The primary segments are:

• Nutritional Supplements: The largest segment, propelled by increasing awareness of deficiencies and preventive health strategies.

• Fortified Foods: Growing demand in emerging markets for fortified infant foods, cereals, and dairy products.

• Cosmetics and Personal Care: Rising use in anti-aging, skincare, and sun protection products.

• Pharmaceuticals: Application in treating vitamin A deficiency-related conditions.

Regional Market Dynamics

• North America: Dominates due to high supplement adoption, regulatory support, and advanced manufacturing capabilities.

• Asia-Pacific: Fastest-growing market driven by rising nutritional deficiency awareness, economic growth, and expanding pharmaceutical and cosmetics sectors.

• Europe: Stable market with focus on natural and organic products, but cautious regulation impacting new product launches.

Key Drivers and Challenges

Drivers:

• Increasing prevalence of vitamin A deficiency globally, particularly in low-income zones.

• Growing consumer preference for fortified foods and dietary supplements.

• Expansion of cosmeceuticals integrating vitamin A derivatives.

Challenges:

• Stringent regulatory frameworks impacting product approval and marketing.

• Potential toxicity concerns at high doses, necessitating rigorous safety assessments.

• Competition from natural vitamin A sources and other retinoids.

---

Market Projections and Future Trends

Forecast Period: 2023–2030

The vitamin A palmitate market is projected to grow at a CAGR of 5.2% over the next seven years, reaching approximately USD 535 million by 2030 [3]. Key factors influencing this trajectory include:

• Innovative Formulations: Advances in nanotechnology and encapsulation techniques are improving bioavailability and stability, expanding application scopes.

• Regulatory Environment: Harmonization of standards is expected to streamline market access, especially in emerging economies.

• Consumer Trends: Rising preference for clean-label and natural ingredients may stimulate demand for synthetic forms like palmitate, which can be more cost-effective and stable than natural extracts.

• Research and Development: Ongoing clinical trials are likely to confirm additional health benefits, broadening the therapeutic use of vitamin A palmitate.

Emerging Opportunities

• Personalized Nutrition: Integration with nutrigenomics to tailor supplementation regimens.

• Cosmetics: Increasing incorporation into skin health products targeting anti-aging and photoprotection.

• Functional Foods: Fortification strategies responding to global malnutrition.

---

Key Market Players and Strategic Movements

Leading manufacturers include BASF SE, DSM Nutritional Products, and Zhejiang Medicine Co., Ltd., investing heavily in R&D and strategic partnerships. For example, DSM's recent acquisition of specialty vitamin portfolios aims to enhance product offerings, diversify customer base, and expand regional presence. Patent filings related to novel stabilization techniques and delivery systems are strengthening competitive moats.

---

Regulatory and Research Outlook

Regulatory agencies continue to evaluate dosage safety, with global guidelines emphasizing upper intake levels (ULs). Scientific evidence from ongoing clinical trials will shape regulations and product claims, impacting market penetration.

Emerging research focusing on vitamin A's role in immune modulation, neurodevelopment, and chronic disease prevention could unlock new therapeutic applications, further expanding the market.

---

Conclusion and Strategic Insights

Vitamin A palmitate's market is poised for sustained growth driven by technological innovations, expanding applications, and increasing health awareness. Businesses should monitor regulatory developments, capitalize on innovation in delivery systems, and tailor marketing strategies to regional consumer preferences. Investment in clinical research remains critical to substantiate health claims and mitigate safety concerns.

---

Key Takeaways

• Clinical validation of vitamin A palmitate's efficacy and safety continues to bolster its market presence, particularly in ocular and skin health sectors.

• Market expansion is driven by rising demand in emerging economies, fortified foods, and cosmeceuticals, with projections indicating a CAGR of over 5% through 2030.

• Technological innovations—including nanotech and encapsulation—are enhancing bioavailability, creating new product opportunities.

• Regulatory landscapes require ongoing vigilance; companies must align product claims with evidence and standards to ensure market access.

• Research-driven differentiation will be essential, particularly as health claims become more scientifically substantiated, opening pathways for novel therapeutic indications.

---

FAQs

Q1: What are the primary therapeutic uses of vitamin A palmitate?
A: Its main applications involve correcting vitamin A deficiency, supporting eye health, and serving as an antioxidant in cosmetic formulations.

Q2: How does vitamin A palmitate compare with natural vitamin A sources?
A: It offers superior stability and bioavailability, allowing for consistent dosing and longer shelf life, particularly in fortified foods and supplements.

Q3: Are there safety concerns associated with high doses of vitamin A palmitate?
A: Yes. Excessive intake can lead to hypervitaminosis A, with symptoms like dizziness, nausea, and in severe cases, liver damage. Regulatory limits guide safe consumption levels.

Q4: Which regions dominate the vitamin A palmitate market?
A: North America leads due to advanced healthcare and supplement markets, while Asia-Pacific is experiencing rapid growth driven by expanding nutraceutical and cosmetics sectors.

Q5: What future research directions could influence the market?
A: Studies exploring vitamin A’s role in immune function, neuroprotection, and chronic disease management could broaden therapeutic indications, stimulating demand.

---

References

[1] Ophthalmic Epidemiology. (2021). "Efficacy of Vitamin A derivatives in AMD."
[2] Journal of Nutritional Science. (2022). "Bioavailability of synthetic vitamin A forms."
[3] Persistence Market Research. (2023). "Vitamin A market outlook."