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Last Updated: May 29, 2022

CLINICAL TRIALS PROFILE FOR VITAMIN A PALMITATE


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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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

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).
NCT00065455 ↗ Investigating the Effect of Vitamin A Supplementation on Retinitis Pigmentosa Completed National Eye Institute (NEI) Phase 1 2003-07-17 Retinitis pigmentosa (RP) is a collective term for a group of inherited retinal dystrophies that are a major cause of irreversible blindness. RP of some type occurs in approximately 1 out of 3500 persons in the United States(1). Gene mutations are responsible for the majority of RP. To date, mutations have been identified in 30 different genes linked to RP(2). The visual prognosis of RP is poor, since the gradual but relentless visual field loss leads eventually to some degree of blindness(3). Although no effective treatment for RP has been identified, participants supplemented with a daily oral dose of 15,000 IU vitamin A palmitate have shown, on average, a slower rate of deterioration of retinal function when the intervention is continued over several years(4). The purpose of this research is to determine whether administration of high oral doses of vitamin A can acutely improve cone photoreceptor function in RP participants as measured by electroretinography (ERG). In this interventional, non-randomized, prospective, pilot study, 5 participants will receive a daily oral dose of 50,000 IU of vitamin A palmitate for 4 weeks, followed by a maintenance dose of 15,000 IU daily for the subsequent 2 weeks. The primary efficacy outcome is a relative percentage change in ERG response amplitude subsequent to vitamin A supplementation. A secondary efficacy outcome is a relative percentage change in implicit time from pre- to post- vitamin A supplementation, with improvement specified as a shorter response implicit time. Other secondary outcomes will be improvements in visual field (Humphery, 10-2; sum of thresholds). Safety outcomes include visual fields, ETDRS visual acuity, intraocular pressure, serum vitamin A level and liver function tests.
NCT00073320 ↗ Intramuscular Injections of Paliperidone Palmitate in the Arm or Buttock of Subjects With Schizophrenia Completed Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Phase 3 2003-08-01 The purpose of the study is to compare the pharmacokinetic parameters (blood concentrations) of i.m. paliperidone palmitate after administration in 2 different injection sites (deltoid or gluteal).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Vitamin A Palmitate

Condition Name

Condition Name for Vitamin A Palmitate
Intervention Trials
Schizophrenia 49
Type 2 Diabetes 4
Insulin Resistance 4
Retinitis Pigmentosa 3
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Condition MeSH

Condition MeSH for Vitamin A Palmitate
Intervention Trials
Schizophrenia 52
Diabetes Mellitus, Type 2 9
Diabetes Mellitus 8
Insulin Resistance 6
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Clinical Trial Locations for Vitamin A Palmitate

Trials by Country

Trials by Country for Vitamin A Palmitate
Location Trials
United States 261
Korea, Republic of 17
Canada 15
Ukraine 12
Taiwan 12
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Trials by US State

Trials by US State for Vitamin A Palmitate
Location Trials
California 20
Texas 19
Missouri 16
Illinois 13
Florida 13
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Clinical Trial Progress for Vitamin A Palmitate

Clinical Trial Phase

Clinical Trial Phase for Vitamin A Palmitate
Clinical Trial Phase Trials
Phase 4 23
Phase 3 30
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Vitamin A Palmitate
Clinical Trial Phase Trials
Completed 79
Recruiting 7
Unknown status 7
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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
Janssen-Cilag International NV 6
Janssen Scientific Affairs, LLC 6
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Sponsor Type

Sponsor Type for Vitamin A Palmitate
Sponsor Trials
Other 92
Industry 54
NIH 17
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