A specific form of vitamin E improved the most severe form of fatty liver disease in some children, according to a study funded by the National Institutes of Health. Results appear in the April 27 issue of the Journal of the American Medical Association. A previous study found vitamin E effective in some adults with the disease.
Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease among U.S. children. NAFLD ranges in severity from steatosis (fat in the liver without injury) to nonalcoholic steatohepatitis or NASH (fat, inflammation, and liver damage). Fatty liver increases a child’s risk of developing heart disease and liver cirrhosis. The only way to distinguish NASH from other forms of fatty liver disease is with a liver biopsy. Weight loss may reverse the disease in some children, but other than dietary advice, there are no specific treatments. Excess fat in the liver is believed to cause injury by increasing levels of oxidants, compounds that damage cells.
Most children with fatty liver disease are overweight and resistant to insulin, a critical hormone that regulates energy. Boys are more likely affected than girls, as are Hispanic children compared to African-Americans and whites.
Using liver biopsies, researchers found that after 96 weeks of treatment, 58 percent of the children on vitamin E no longer had NASH, compared to 41 percent of the children on metformin (a diabetes drug), and 28 percent on placebo. Vitamin E was better than placebo because it significantly reduced enlargement and death of liver cells.
"These results suggest that vitamin E improves or resolves NASH in at least half of children, which we previously showed to be true in adults," said Stephen P. James, M.D., director of the digestive diseases and nutrition division at NIH's National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which funded the study. While the results are encouraging, patients using vitamin E for NASH should be under a doctor’s care. "We hope to build on these results by looking for other therapies and reliable, non-invasive ways to monitor the disease and response to therapy."
The Treatment of Nonalcoholic Fatty Liver Disease in Children (TONIC) trial studied whether vitamin E (an antioxidant) or metformin could improve fatty liver disease. The endpoint to measure success was either a sustained reduction in the liver enzyme alanine aminotransferase (ALT) or improvements in the liver as shown by biopsies. A total of 173 children, mostly whites and Hispanics ages 8 to 17, were recruited into three treatment groups. The children received either 500 milligrams of metformin or 400 international units of a natural form of vitamin E or placebo twice a day for two years.
Neither vitamin E nor metformin were significantly better than placebo in reducing ALT levels. Twenty-six percent of patients on vitamin E, 16 percent on metformin, and 17 percent of those on placebo had reduced liver enzyme levels. Interestingly, ALT levels improved more rapidly among patients on vitamin E (within six months) compared to those on placebo. The ALT levels among the children on placebo improved over the two years.
"We believe all children in the trial benefited from the frequent diet and exercise advice provided throughout the study," said Joel E. Lavine, M.D., Ph.D., a TONIC principal investigator and professor of pediatrics at Columbia University, New York. "Now we have information on the natural history of a placebo group over time, which will help us design future trials."
Using biopsies in children with liver disease is unique. "TONIC is ground-breaking on two fronts. It is the first study to use liver biopsy to evaluate potential treatments for any liver disease in children," said Patricia Robuck, Ph.D., M.P.H., the project scientist at NIDDK. "It is also the first multi-center, randomized, controlled trial to use a liver biopsy to evaluate a therapy for fatty liver in children, considered the most rigorous design for studies of liver disease."
TONIC was conducted by NASH Clinical Research Network investigators at:Case Western Reserve University and the Cleveland Clinic, Cleveland
Additional NIH support for TONIC was provided by the National Cancer Institute, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Center for Research Resources. Learn more about TONIC at www.clinicaltrials.gov (search for NCT00063635) and about the NASH network at http://www.jhucct.com/nash/open/centers/centers.htm.
The NIDDK, a component of the NIH, conducts and supports research on diabetes and other endocrine and metabolic diseases; digestive diseases, nutrition and obesity; and kidney, urologic and hematologic diseases. Spanning the full spectrum of medicine and afflicting people of all ages and ethnic groups, these diseases encompass some of the most common, severe and disabling conditions affecting Americans. For more information about the NIDDK and its programs, see www.niddk.nih.gov.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
Leslie Curtis | EurekAlert!
Inflammation Triggers Unsustainable Immune Response to Chronic Viral Infection
24.10.2016 | Universität Basel
Resolving the mystery of preeclampsia
21.10.2016 | Universitätsklinikum Magdeburg
Terahertz excitation of selected crystal vibrations leads to an effective magnetic field that drives coherent spin motion
Controlling functional properties by light is one of the grand goals in modern condensed matter physics and materials science. A new study now demonstrates how...
Researchers from the Institute for Quantum Computing (IQC) at the University of Waterloo led the development of a new extensible wiring technique capable of controlling superconducting quantum bits, representing a significant step towards to the realization of a scalable quantum computer.
"The quantum socket is a wiring method that uses three-dimensional wires based on spring-loaded pins to address individual qubits," said Jeremy Béjanin, a PhD...
In a paper in Scientific Reports, a research team at Worcester Polytechnic Institute describes a novel light-activated phenomenon that could become the basis for applications as diverse as microscopic robotic grippers and more efficient solar cells.
A research team at Worcester Polytechnic Institute (WPI) has developed a revolutionary, light-activated semiconductor nanocomposite material that can be used...
By forcefully embedding two silicon atoms in a diamond matrix, Sandia researchers have demonstrated for the first time on a single chip all the components needed to create a quantum bridge to link quantum computers together.
"People have already built small quantum computers," says Sandia researcher Ryan Camacho. "Maybe the first useful one won't be a single giant quantum computer...
COMPAMED has become the leading international marketplace for suppliers of medical manufacturing. The trade fair, which takes place every November and is co-located to MEDICA in Dusseldorf, has been steadily growing over the past years and shows that medical technology remains a rapidly growing market.
In 2016, the joint pavilion by the IVAM Microtechnology Network, the Product Market “High-tech for Medical Devices”, will be located in Hall 8a again and will...
14.10.2016 | Event News
14.10.2016 | Event News
12.10.2016 | Event News
24.10.2016 | Earth Sciences
24.10.2016 | Life Sciences
24.10.2016 | Physics and Astronomy