Vitamin D2 effectively treats vitamin D deficiency

A new study by researchers at Boston University School of Medicine researchers has shown that 50,000 International Units (IU) of vitamin D2, given weekly for eight weeks, effectively treats vitamin D deficiency.

Vitamin D2 is a mainstay for the prevention and treatment of vitamin D deficiency in children and adults.

Continued treatment with the same dose of vitamin D2 every other week for up to six years after the initial eight-week period prevents vitamin D deficiency from recurring with no toxicity.

Vitamin D is essential for strong bones because it helps the body absorb calcium and phosphorus from the food we eat.

Vitamin D deficiency can lead to rickets in children and the painful bone disease osteomalacia in adults. Vitamin D deficiency can also cause osteoporosis and has been linked to increased risk of cancer, heart disease, diabetes, autoimmune diseases and infectious diseases including influenza.

Of the 86 patients researchers studied, 41 patients who were vitamin D deficient received eight weeks of 50,000 IU of vitamin D2 weekly prior to starting maintenance therapy.

For those patients, the mean pre-treatment 25-hydroxyvitamin D status (25(OH)D) level was 19 ng/ml, which increased to 37 ng/ml after eight weeks of weekly therapy. These patients were then treated with 50,000 IU of vitamin D2 every other week and had a mean final 25(OH)D level of 47 ng/ml.

For the 45 patients who received only maintenance therapy of 50,000 IU of vitamin D2 every two weeks, the mean pre-treatment 25(OH)D level was 27 ng/ml and the mean final level was 47 ng/ml.

‘Vitamin D2 is effective in raising 25(OH)D levels when given in physiologic and pharmacologic doses and is a simple method to treat and prevent vitamin D deficiency,’ said senior author Michael F. Holick, PhD, MD, director of the Bone Healthcare Clinic and the Vitamin D, Skin and Bone Research Laboratory at Boston University School of Medicine.

‘While treating and preventing vitamin D deficiency, these large doses of vitamin D2 do not lead to vitamin D toxicity,’ he added.

According to Holick, this is the first study demonstrating the efficacy of a prescription therapy to prevent vitamin D deficiency long-term in routine clinical practice.

The study appears online in the journal Archives of Internal Medicine.



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Latest analysis confirms suboptimal vitamin D levels in millions of US children

Millions of children in the United States between the ages of 1 and 11 may suffer from suboptimal levels of vitamin D, according to a large nationally representative study published in the November issue of Pediatrics, accompanied by an editorial.

The study, led by Jonathan Mansbach, MD, at Children's Hospital Boston, is the most up-to-date analysis of vitamin D levels in U.S. children. It builds on the growing evidence that levels have fallen below what's considered healthy, and that black and Hispanic children are at particularly high risk.

Both the optimal amount of vitamin D supplementation and the healthy blood level of vitamin D are under heated debate in the medical community. Currently, the American Academy of Pediatrics recommends children should have vitamin D levels of at least 50 nmol/L (20 ng/ml). However, other studies in adults suggest that vitamin D levels should be at least 75 nmol/L (30 ng/ml), and possibly 100 nmol/L (40 ng/ml), to lower the risk of heart disease and specific cancers.

Mansbach and collaborators from the University of Colorado Denver and Massachusetts General Hospital used data from the National Health and Nutrition Examination Survey (NHANES) to look at vitamin D levels in a nationally representative sample of roughly 5,000 children from 2001-2006. Extrapolating to the entire U.S. population, their analysis suggests that roughly 20 percent of all children fell below the recommended 50 nmol/L. Moreover, more than two-thirds of all children had levels below 75 nmol/L, including 80 percent of Hispanic children and 92 percent of non-Hispanic black children.

"If 75 nmol/L or higher is eventually demonstrated to be the healthy normal level of vitamin D, then there is much more vitamin D deficiency in the U.S. than people realize," Mansbach says.

Mansbach and his co-authors suggest that all children take vitamin D supplements, because of the generally low levels that they found and the potential health benefits of boosting vitamin D to normal levels. Vitamin D improves bone health and prevents rickets in children, and recent studies suggest that it also may prevent a host of common childhood illnesses, including respiratory infections, childhood wheezing, and winter-related eczema.

Although sun exposure generates healthy doses of vitamin D, it can also cause skin cancer. Dermatologists and the AAP recommend wearing sunblock, but this actually blocks our skin's ability to make vitamin D. Furthermore, children with more highly pigmented skin require much more sun exposure than fair-skinned children to obtain healthy levels of vitamin D. Vitamin D can also be obtained from certain foods, like liver and fatty fish, but almost all children in the U.S. don't consume these foods in high enough quantities to match the vitamin D that could be provided by summer sunshine or vitamin D supplements.

In the study, children taking multi-vitamins that included vitamin D had higher levels overall, but this accounted for less than half of all children. Mansbach recommends that all children take vitamin D supplements, especially those living in high latitudes, where the sun is scarce in the wintertime.

"We need to perform randomized controlled trials to understand if vitamin D actually improves these wide-ranging health outcomes," Mansbach says. "At present, however, there are a lot of studies demonstrating associations between low levels of vitamin D and poor health. Therefore, we believe many U.S. children would likely benefit from more vitamin D."

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Total Nutraceutical Solutions To Launch Natural Organic Whole Food Mushroom Vitamin D Supplement

Recent Studies Reveal Worldwide Deficiencies in Vitamin D Levels

Total Nutraceutical Solutions, Inc. (TNS) (OTCBB:TNUS), announced today that the
company has formulated and will launch a unique natural whole food
mushroom-based Vitamin D supplement. This supplement is plant-based and not
animal-based and provides a new approach to Vitamin D supplementation in
health-conscious individuals. A proprietary grown mushroom, Agaricus blazei
Murill (AbM) by Sylvan Bio, Inc. and Creekside Mushrooms Limited will be
stimulated with UV light to produce natural organic Vitamin D2 within the
mushroom. The need for this product is underscored by the following statement in
the October 26, 2009 issue of the Archives of Internal Medicine: "The worldwide
prevalence of Vitamin D deficiency is striking and more than 40% of the
population may be Vitamin D deficient." (Vol.169 No.19, pp.1806-1808).The
importance of the timing of this product launch and the need for a natural whole
food form of Vitamin D is further evidenced by a recent statement by the Office
of Dietary Supplements, National Institutes of Health, that the second-best
source of Vitamin D is 3 ounces of mushrooms enriched with Vitamin D. Many
medical organizations, including the American Academy of Pediatricians, have
advocated increased intake of Vitamin D, especially in children. Children`s
Hospital Boston reports that 62% of children taking multivitamins had below
normal levels of vitamin D (USA Today, October 26, 2009). TNS has developed
technologic capability that will allow production of a daily oral encapsulated
natural supplement that contains enough Vitamin D equal to or greater than ten
8-ounce servings of Vitamin D fortified milk, at a cost that is affordable by
most people.

According to the 2005 Dietary Guidelines for Americans, "nutrient needs should
be met primarily through consuming foods. Foods provide an array of nutrients
and other compounds that may have beneficial effects on health."
(http://www.health.gov/dietaryguidlines/dga2005/document/default.htm) This
statement was recently supported by a TNS experiment that revealed that
ingestion of a natural organic edible whole food could increase biologic
survival in a nutritionally deprived organism. Unaltered and Vitamin D2 enriched
dried powders of the mushroom Agaricus blazei Murill by Sylvan significantly
increased survival above controls, 4% and 15% respectively (TNUS.OB; September
30, 2009).

Vitamin D, also called the "sunshine vitamin," has recently received much
attention as a needed nutritional supplement to improve human health. Decreased
levels of Vitamin D have been associated with a range of diseases, such as
osteoporosis, osteoarthritis, cancer of the breast, diabetes, cardiovascular
disease, and many others.

TNS has purchased a Steripulse - XL 3000 Pulsed UVB light system from Xenon
Corporation, Wilmington, MA, and the system is being installed at Columbia
Nutritional Services, Vancouver, WA, the TNS contract manufacturer. TNS has
acquired from The Penn State Research Foundation (PSRF) an option to license an
invention entitled "Rapid Generation of Vitamin D2 from Mushrooms and Fungi
Using Pulsed UV-light" (The Invention). A U.S. Provisional Patent Application
was filed on April 23, 2008 and names Professor Robert B. Beelman, and Graduate
Student Michael Kalaras as co-inventors, Department of Food Science,
Pennsylvania State University (PSU).

"As a doctor, I receive no greater pleasure than having the opportunity to
create products that can help people live longer and healthier lives," stated
Marvin S. Hausman MD, CEO, Total Nutraceutical Solutions, Inc. "Vitamin D
deficiency is worldwide, is implicated in many diseases, and this product has
the potential to provide a needed nutritional answer to this problem."

"I am very excited that our new process is being commercially utilized to
produce Vitamin D-rich dietary supplements made from the highly nutritious
Agaricus blazei mushroom," stated Robert B. Beelman Ph.D., Professor of Food
Science, Pennsylvania State University. "I believe this product will be the
first of its kind made from a whole food that will appeal to health conscious
individuals that desire to consume a plant-based diet."

Sylvan Bio, Inc. is an emerging leader in providing innovative fungal products
to a variety of industries. Based in Kittanning, Pennsylvania, it is a wholly
owned subsidiary of Sylvan Inc., also based in Kittanning. Sylvan Inc. serves
mushroom, agricultural and nutraceutical markets through its prominence in
fungal technology and solid-substrate fermentation.

Creekside Mushrooms Limited is the largest single site fully integrated and
highly technological "underground" mushroom growing farm in the world.
Creekside`s unique underground farm is scientifically monitored to provide ideal
year-round growing conditions to consistently produce the highest quality
mushrooms, which are 100% organic.

About Total Nutraceutical Solutions, Inc.:

Total Nutraceutical Solutions, Inc. (TNS), is an emerging nutraceutical company
with a focus on discovering, formulating and marketing products composed
primarily of organic natural mushroom compounds that contain bioactive nutrients
for potential health benefits. TNS develops production and analytic technologies
for food and nutritional supplements composed primarily of mushrooms and their
mycelial biomasses. Novel clinical models and biomarkers are used to show
nutritional and clinical efficacy of our products. In addition to preventative
healthcare formulations and nutritional approaches to a wide variety of human
conditions and illnesses, TNS also develops and acquires breakthrough
nutritional tools and products in the fields of animal husbandry and livestock
feeds.

Any statements contained in this press release that relate to future plans,
events or performance are forward-looking statements that involve risks and
uncertainties, including, but not limited to, the risks associated with
thetransactiondescribed in this press release, and other risks identified in the
filings by Total Nutraceutical Solutions (TNS), Inc., with the Securities and
Exchange Commission. Further information on risks faced by TNS are detailed in
the Form 10-K for the year ended December 31, 2008, and in its subsequent
Quarterly Reports on Form 10-Q. These filings are or will become available on a
website maintained by the Securities and Exchange Commission at
http://www.sec.gov. The information contained in this press release is accurate
as of the date indicated. Actual results, events or performance may differ
materially. TNS does not undertake any obligation to publicly release the result
of any revision to these forward-looking statements that may be made to reflect
events or circumstances after the date hereof or to reflect the occurrence of
unanticipated events.

Total Nutraceutical Solutions, Inc.
Roberta Matta, 509-427-5132
www.totalnutraceutical.com



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Study Suggest Vitamin D Levels Too Low for 1 in 5 U.S. Children, Daily Dose is 4 cups of milk

1 in 5 kids get little vitamin D, study says....

At least one in five U.S. children aged 1 to 11 don’t get enough vitamin D and could be at risk for a variety of health problems including weak bones, the most recent national analysis suggests.

By a looser measure, almost 90 percent of black children that age and 80 percent of Hispanic kids could be vitamin D deficient — “astounding numbers” that should serve as a call to action, said Dr. Jonathan Mansbach, lead author of the new analysis and a researcher at Harvard Medical School and Children’s Hospital in Boston.

The findings add to mounting evidence about vitamin D deficiency in children, teens and adults, a concern because of recent studies suggesting the vitamin might help prevent serious diseases, including infections, diabetes and even some cancers.

While hard evidence showing that low levels of vitamin D lead to disease or that high levels prevent it is lacking, it’s a burgeoning area of research.

Exactly how much vitamin D children and adults should get, and defining when they are deficient, is under debate. Doctors use different definitions, and many are waiting for guidance expected in an Institute of Medicine report on vitamin D due next year. The institute is a government advisory group that sets dietary standards.

The new analysis, released online Monday by the journal Pediatrics, is the first assessment of varying vitamin D levels in children aged 1 through 11.

Previous studies in the journal this year found low levels were prevalent in U.S. teens, and also showed kids with low levels had higher blood pressure and cholesterol levels, and were more likely to be overweight.

The new analysis uses data from a 2001-06 government health survey of nearly 3,000 children. They had blood tests measuring vitamin D levels.

Using the American Academy of Pediatrics’ cutoff for healthy vitamin D levels, 6.4 million children — about 20 percent of kids that age — have blood levels that are too low. Applying a less strict, higher cutoff, two-thirds of children that age, including 90 percent of black kids and 80 percent of Hispanics, are deficient in vitamin D.

A Pediatrics editorial says the strongest evidence about effects of vitamin D deficiency in kids involves rickets, a bone disease common a century ago but that continues to occur.

Rickets can be treated and prevented with 400 units daily of vitamin D, the editorial says. The pediatricians’ group recently recommended that amount for all children, saying that most need vitamin supplements.

Mansbach says his study, funded by the National Institutes of Health, supports that recommendation.

Children can get 400 units daily by drinking four cups of fortified milk, or eating lots of fish, but many don’t do that.

The body also makes vitamin D when sunlight hits the skin, but many children don’t spend enough time outdoors. That’s one reason why lower vitamin D levels are found in children living in colder climates and those with darker skin, which absorbs less sunlight.



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Scientific evidence of vitamin D's vast benefits is building ( Part 3 )

With vitamin D, he added, "You still have these same problems, but the data is pretty clear that vitamin D is providing a benefit. The evidence is gathering more steam."

A bone builder

Because it's critical in the absorption of calcium, vitamin D long has been recognized as important in building strong bones. Said Klamm, historically, vitamin D deficiency was associated with rickets, a softening of bones in children.

While few children are diagnosed with rickets these days, many are nonetheless low in vitamin D.

"It's pretty clear that somewhere in the neighborhood of half of all people under the age of 18 don't get enough vitamin D," Hall said.

The problem exists even among nursing infants.

"We used to think breast milk was the ideal food," Klamm said. "It turns out there's not much vitamin D in breast milk."

Though bone-building seems most critical for the young, it's just as if not more important for the old, whose skin makes vitamin D far less efficiently. At age 20, spending 20 unprotected minutes in the sun twice a week is all it takes for you body to manufacture sufficient vitamin D, Cardelli said; by age 70, the number climbs to 80 minutes.

Klamm said studies in nursing homes have proven that vitamin D supplementation is helpful in improving both bone and muscle strength. He added that some elite athletes now train at altitude near the equator for similar reasons: They believe that the extra vitamin D their skin creates in such a setting boosts performance.

Though the jury's still out on vitamin D's conclusive capabilities, plenty of people are taking it in the meantime.

"You never know because it's never the only thing going on with you. All I know is it didn't hurt me at all, and I haven't even had a cold in 2½ years," Barry said.



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Swine Flu Prevention Should Include Vitamin D

As the country battles the swine flu, supplementing with Vitamin D is a good way to boost immunity, but only by taking adequate amounts.

Vitamin D has received increased attention due to its crucial role in disease prevention and immune response.

People deficient in vitamin D who don't get enough sun may need to supplement, particularly during winter months. D3 or cholecalciferol is the form the Vitamin D Council recommends, and in sufficient amounts. Vitamin D Useful Against Cancer, Bone Issues, Colds & Flu, and More.

Despite the name, vitamin D isn't a vitamin; it's a secosteroid hormone that targets over 2000 genes in the human body. Vitamin D has been shown, according to the Vitamin D Council, to have a positive affect on bone health, immunity, cancer prevention and inflammation. Vitamin D3 is made in large quantities when sunlight strikes bare skin. Ergocalciferol, also referred to as vitamin D2 or Calciferol is available, but it isn't the naturally occurring form of vitamin D in humans.

Dr. John Jacob Cannell, MD, Vitamin D Council’s Executive Director, notes on their website that current research links Vitamin D deficiency to at least 17 variations of cancer as well as heart disease, stroke, hypertension, autoimmune diseases, diabetes, depression, chronic pain, osteoarthritis, osteoporosis, muscle weakness, muscle wasting, birth defects, periodontal disease, and more.

In addition, vitamin D promotes calcium absorption in the gut and maintains adequate serum calcium and phosphate concentrations. This critical substance is needed for bone growth and remodeling, and without a sufficient amount, bones can become thin, brittle, or misshapen. Vitamin D can prevent rickets in children, osteomalacia in adults, and can help protect older adults from osteoporosis.


Vitamin D: Flu Season & the Sunshine Link

Most vitamin D is created from exposure to UV-B radiation from the sun. As a result, vitamin D deficiency is more common in the winter, when cold and flu levels reach their peak in populations.The rapid spread of the flu usually stops by May when population 25(OH) D levels quickly rise.

A large study appearing in the February 2009 Archives of Internal Medicine found that people with the lowest blood vitamin D levels reported having more recent colds or flu. The risks rose in adults and children who had acute or chronic respiratory disorders. "The findings of our study support an important role for vitamin D in prevention of common respiratory infections, such as colds and the flu," says Adit Ginde, MD, MPH, UC Denver Division of Emergency Medicine and lead author of the study.

There are no significant dietary sources of vitamin D, so unless people get adequate sun exposure or take supplements during the winter months, their immune system is easily compromised.
How Vitamin D Fights Colds and Flu

The body's immune system naturally produces antimicrobial, (destroying or inhibiting the growth of microorganisms), peptides or (AMPs). These AMPs won't work with every virus it comes in contact with, but for the ones they do, the body's immune system automatically springs into action.

When microbes like the influenza virus reach upper respiratory airways, they stimulate the production of an enzyme that converts 25(OH)D, the circulating inactive form of vitamin D, into the hormonally active 1,25(OH)2D (1,25-dihydroxyvitamin D). 1,25(OH)2D is needed to activate the genes that produce antimicrobial peptides.

Bottom line, without vitamin D there is no innate immunity in the body.
Vitamin D Levels Must Be High Enough To Aid Flu Prevention

Although the risk of vitamin D3 toxicity is very unlikely, people's fear of overdosing remains high.

Dr. Cannell and other vitamin D researchers recommend taking enough Vitamin D3 to get 25(OH)D levels above "substrate starvation levels," 50 ng/mL or 125 nmol/L. Current recommendations are inadequate to maintain optimal health, and certainly to prevent or treat colds and flu.

The Vitamin D Council recommends people supplement with vitamin D before getting a blood test, then adjust their dose so their 25(OH)D level is between 50–80 ng/ml during both the summer and the winter. The council cautions that these are conservative dosage recommendations. People who avoid the sun, and nearly all dark-skinned people need to increase their dose if their blood levels are still low, even after two months of the above dosage, particularly during the winter months.

Exact levels, explains Dr. Cannell, are difficult to determine because requirements vary by age, body weight, percent of body fat, latitude, skin coloration, season of the year, use of sun block, individual variation in sun exposure, and how sick someone is.

“If you use suntan parlors once a week,” says Dr. Cannell, “or if you live in Florida and sunbathe once a week, year-round, do nothing.” However, if you receive very little UVB exposure the Council recommends the following dosing levels of D3:

* Health children under the age of 2 - 1,000 IU per day*
* Healthy children over the age of 2 - 2,000 IU per day*
* Adults and adolescents - 5,000 IU per day.

*The American Academy of Pediatrics recommends 400 mg per day for children.

Consult with a health care provider before taking vitamin D, particularly if you have any of the following conditions: sarcoidosis, primary hyperparathyroidism, granulomatous disease, or other conditions that cause high blood calcium.

Vitamin D has received increased attention due to it's critical role in bone health, cancer prevention and immunity. People who test low or who have risk factors need to supplement. Take the optimal form and dose particularly during the winter months to prevent and treat colds and flu.




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Scientific evidence of vitamin D's vast benefits is building (Part 2)

There are vitamin D receptors on the body's immune cells," he said. His perspective: "They're there for some reason."
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Added Cardelli, "There is evidence also that our white blood cells are more effective at killing germs if our vitamin D level is higher."

To Barry's dosage concern, Klamm would respond in much the same way Barry's own health care provider did: The balance between the risks and benefits of vitamin D supplementation leans pronouncedly to the side of benefits.

"It's almost impossible with over-the-counter vitamin D to get too much," Cardelli said.

For those wanting to take action to prevent flu this fall and winter, Klamm said, "vaccinating is a good idea, washing hands is a good idea and taking vitamin D is a good idea. It's easy, and it's cheap."

A cancer preventive

Scientists further speculate that vitamin D plays a role in fending off cancer, particularly of the colon and breast. Two factors enter into their suspicion.

First, these diseases occur more frequently further from the equator, where more people are deficient in vitamin D.

"(Scientists) noted that there's a correlation between where you live on the planet and risk for certain diseases," Cardelli said.

Second, like immune cells, the tissues affected by several cancers have vitamin D receptors. Klamm said again, "If you either believe in evolution or the good Lord, there's a reason for them being there."

While the mechanisms of vitamin D's cancer-fighting effects are not yet understood or proven, every month sees new scientific articles published on the topic, said Dave Hall, Ph.D., associate professor of chemistry at Lawrence University in Appleton.

"There's a lack of vitamin D, and now researchers are going in and asking the questions," Hall said.

Answering them is a long and involved process.

"You have to do a prevention study, which takes a long time and a lot of people," Cardelli said.

"It's extremely difficult to examine nutrients and look at health effects," Hall said. "We hear a lot of different things about, 'Well, you don't have enough vitamin E in your diet,' or vitamin C, and there are a lot of conflicting studies."



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