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CLINICAL TRIALS PROFILE FOR VITAMIN A PALMITATE

Clinical Trials for Vitamin A Palmitate

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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)	N/A	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	2003-07-01	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).
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