CLINICAL TRIALS PROFILE FOR VITAMIN A PALMITATE
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505(b)(2) Clinical Trials for VITAMIN A PALMITATE
| 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 | >Sponsor | >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). |
| NCT00074477 ↗ | Safety and Efficacy of an Anti-Psychotic in Patients With Schizophrenia | Completed | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Phase 2 | 2003-10-01 | The purpose of this study is to determine the efficacy (how well the drug works), safety, and side effects of paliperidone palmitate injection compared to placebo in the treatment of the symptoms of schizophrenia in adults. The placebo used in this study was a nutritional substance known as 20% Intralipid emulsion given to patients requiring intravenous feedings. |
| NCT00101634 ↗ | Efficacy and Safety of a Long Acting Anti-Psychotic Versus Placebo in Patients With Schizophrenia | Completed | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Phase 3 | 2004-12-01 | The purpose of this study is to determine the efficacy (how well the drug works), safety, and side effects of paliperidone palmitate compared to placebo in the treatment of the symptoms of schizophrenia in adults. The placebo used in this study was a nutritional substance known as 20% Intralipid emulsion given to patients requiring intravenous feedings. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for VITAMIN A PALMITATE
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Clinical Trial Sponsors for VITAMIN A PALMITATE
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| 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) | 7 |
| Janssen Research & Development, LLC | 6 |
| [disabled in preview] | 22 |
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