Category Archives: Supplements

New Study: Vitamin B12 Didn’t Improve Memory, But That Doesn’t Mean You Shouldn’t Take It

VitaminB12Molecule2

See that cobalt-colored sphere at the center of this molecule? That’s the mineral cobalt. It is the active component of B12.

A new study (and a good one: multicenter, double-blind, randomized, placebo-controlled) found no cognitive benefit for taking a supplement containing B12 plus folic acid:

Results Of 2-Year Vitamin B Treatment On Cognitive Performance, Neurology, 12 November 2014

The study included 2,919 people over 65 who had elevated homocysteine levels. Higher homocysteine is seen in people with dementia. Certain B vitamins, including the ones tested here, have been shown to lower homocysteine. The thinking was if you could lower homocysteine, you could reduce risk for dementia. B12 plus folic acid weren’t any better than placebo in this study, even though they did lower homocysteine:

“This study provides Class I evidence that 2-year supplementation with folic acid and vitamin B12 in hyperhomocysteinemic elderly people does not affect cognitive performance.”

People absorb less vitamin B12 as they age. Some develop outright deficiencies. It doesn’t matter whether they eat a lot of meat or are strict vegetarians. I wrote about that in The Case For Taking A Vitamin B12 Supplement. The people in this study were taking a lot of B12 – 500 micrograms a day (and 400 micrograms of folic acid). You only need about 2 or 3 micrograms a day. So, you can’t say they weren’t taking enough. You could say that cognitive function depends on other factors besides that one supplement.

B12 is needed for many processes. I’m still convinced it’s a good decision for older people to take it as a supplement and not rely on food. Even the government thinks so:

“Adults older than 50 years [should] obtain most of their vitamin B12 from vitamin supplements or fortified foods.”

The BBC covered this story:
Dementia Study Questions Advice On Taking Supplements, BBC, 13 November 2014

World’s Largest Clinical Trial Testing Vitamin D and Omega-3 (VITAL Study)

VITALStudyThe VITAL Study began in July, 2010 and should wrap up by October, 2017.

“VITAL is an ongoing research study in 25,875 men and women across the U.S. investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk for developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses.”

This is a large, long (five-year), randomized, double-blind, placebo-controlled study. It’s going to be telling. They’ll also be recording negative effects of the supplements. Participants are men aged 50 or older, and women aged 55 or older. So results won’t be generalizable to a younger population, not technically.

One of the lead investigators, Dr. Manson, said:

“Many people had high hopes for vitamin E, vitamin C, beta-carotene, folic acid, selenium and other supplements as preventive tools for many diseases, but large-scale trials didn’t confirm the hoped-for benefits and even found some risks when consumed at higher levels. Let’s not jump on the bandwagon to take mega-doses of these supplements before clinical trials help to clarify their role.”

The Institute of Medicine (IOM) which sets the nation’s RDAs recently (in 2010) upped their recommended daily intake for vitamin D to 600 IUs for people aged 1 to 70, and 800 IUs for 71 and older. It used to be 400-600 IUs for these groups. This assumes little to no sun exposure. They said more research is needed to determine if higher doses are useful or pose health risks, questions this study was designed to answer.

They also may be able to weigh in on the link between omega-3 and prostate cancer, at least what 5 years can tell you. Recall there was a study last year which found that men with high blood levels of omega-3 fatty acids were more likely to develop prostate cancer:

Plasma Phospholipid Fatty Acids and Prostate Cancer Risk in the SELECT Trial, Journal of the National Cancer Institute, July 2013

“Conclusions: This study confirms previous reports of increased prostate cancer risk among men with high blood concentrations of [long-chain omega-3]-PUFA. The consistency of these findings suggests that these fatty acids are involved in prostate tumorigenesis. Recommendations to increase LCω-3PUFA intake should consider its potential risks.”

Something to look forward to.

Here’s the study as filed in ClinicalTrials.gov.

The Case For Taking A B12 Supplement

VitaminB12ADAMIf you’re depending on food to supply your vitamin B12, and you’re over 50, there’s a good chance you’re going to end up with a B12 deficiency. It doesn’t matter if your diet includes plenty of animal food. It’s not intake that’s the problem, it’s absorption. An older body is not the same as a younger body. Grey hair and muscle loss we can see; dwindling ability to absorb certain nutrients is invisible.

Dr. Lindsay Allen from the University of California, Davis, writing in the AJCN, says:

How Common Is Vitamin B-12 Deficiency?, Lindsay H Allen, American Journal of Clinical Nutrition (AJCL), February 2009

Vitamin B-12 deficiency and depletion are common in wealthier countries, particularly among the elderly. … The 2 main causes of vitamin B-12 deficiency are inadequate dietary intake and, in the elderly, malabsorption of the vitamin from food. Contrary to popular belief, not only strict vegetarians (vegans) are at high risk of vitamin B-12 deficiency, and there is strong evidence that status reflects usual intake across a wide range. … Malabsorption of vitamin B-12 from food is the main cause of deficiency in the elderly and explains why depletion occurs with aging.

Vitamin B12 follows a rather circuitous path to absorption. First, of course, you have to eat it. Then you have to free it from the proteins to which it’s bound, so you need a healthy amount of stomach acid. Stomach acid levels decline as we age. They’re also affected by drugs like antacids which are taken for gastric conditions that occur more frequently in the elderly. Once the vitamin is freed, it must bind to a specific protein called Intrinsic Factor (IF) which is secreted by cells that line the stomach. That’s a major stumbling block right there. Anything that damages those parietal cells will cause outright B12 deficiency. (Some people don’t secrete much IF to begin with.) Like? … Ulcers, tumors, scar tissue from ulcers & tumors, any kind of inflammation or gastritis, alcohol intake, and, naturally, the removal of these cells through weight loss or cancer surgery. Intrinsic Factor also doesn’t bind well in an acidic environment. Remember we needed an acidic environment, a low pH, to release B12 from its protein source? Well, now we need a higher pH, about 7, for binding. The pancreas releases buffers to raise the pH of gastric juice. Anything that interferes with pancreatic secretion (diabetes, cancer, cystic fibrosis, etc.) will interfere with B12 absorption. Right, now the IF-B12 complex travels to the small intestine where it’s absorbed. B12 needs to be freed from IF. The pancreas would have secreted enzymes to do that. No enzymes? Poor absorption. Finally it gets absorbed. Any damage to the lower part of the small intestine (celiac disease or other gluten-induced damage, cancer surgery, scar tissue, overrun by bacteria from the colon) will result in poor B12 absorption.

Given all these potential roadblocks, it’s a wonder we get any B12 into us at all.  Many of us struggle. Dr. Allen, citing the Framingham Offspring Study, says that between 4%-6% of US adults over 40 are outright deficient.  But a lot more suffer with low levels:

Marginal depletion (serum vitamin B-12: 148–221 pmol/L) was more common and occurred in ≈14–16% of those aged 20–59 y and greater than 20% of those older than 60.

Over a quarter of older Americans are coping with B12 depletion or full-blown deficiency! Why is this problem coming to the fore now?

This prevalence was underestimated in the past for several reasons, including the erroneous belief that deficiency is unlikely except in strict vegetarians or patients with pernicious anemia, and that it usually takes ≈20 y for stores of the vitamin to become depleted.

Absorption rates are higher for B12 that is not food-bound. And you don’t need much, just 1 or 2 micrograms. Any more and the receptors get overloaded, the rest passes out with stool:

In older persons, food-bound cobalamin malabsorption becomes the predominant cause of deficiency, at least in part due to gastric atrophy, but it is likely that most elderly can absorb the vitamin from fortified food.

Plasma vitamin B-12 concentrations plateaued at intakes greater than 10 μg/d in the Framingham Offspring Study. … Although greater than 70% of the vitamin is absorbed when intake is in the range of 0.1–0.5 μg, the ileal receptors for the vitamin B-12–intrinsic factor complex become saturated with higher intakes such that absorption falls to ≈50% of a 1-μg dose, 15% of a 10-μg dose, and 3% of a 25–50-μg dose. … About 1% of a high dose will be absorbed by passive diffusion, independently of gastric function or intrinsic factor.

Look at that. Just 3% of a 25 microgram dose gets absorbed. It’s hard to find a B12 supplement under 500 micrograms! It’s a case of “value-added.” They can charge more, but you don’t get more.

My opinion… If you’re over 50, even if you don’t believe in taking supplements, take vitamin B12. Don’t rely on food. Eating meat won’t cure a deficiency. This is one time where the government’s National Institutes Of Health is right:

“Adults older than 50 years [should] obtain most of their vitamin B12 from vitamin supplements or fortified foods.”

Dr. Oz Pitching Supplements Is Not The Problem, Poor Regulation Is The Problem

At 6:18 … Wow:

“More people wrote to Congress about the supplement bill than wrote about the Vietnam War.”

I loved that milk analogy, where one in three is a mystery fluid.

People are all fired up about GMOs: “We have a right to know what’s in our food!” but not about contaminants in supplements, “We have a right to be kept in the dark about what’s in our vitamin pills!”

It’s weird, but it’s what people seem to want … no assuredness that what’s on a label is actually in the bottle, that no heavy metals, pesticides or other toxins are present, that the supplement is safe to take at any dose, for any person, with any condition. Dr. Oz isn’t at fault. His promotion of supplements is, as Oliver says, just a symptom of the larger problem of poor regulation.

The GAO Tested Dietary Supplements, They’re A Lot Dirtier Than You Think

The US Government Accountability Office (GAO) was asked if they would conduct an investigation into supplements, specifically:

  1. Whether sellers of herbal dietary supplements are using deceptive or questionable marketing practices.
  2. Whether selected herbal dietary supplements are contaminated with harmful substances.

Did you know that people with type 1 diabetes (their bodies make little to no insulin) can go off insulin shots altogether by taking dietary supplements? In fact, dietary supplements can replace all prescription drugs. Yes. Fish oil can replace all of your meds. Supplements “can correct any health condition,” even Alzheimer’s Disease. That’s what sellers told the GAO.

Here are some clips of GAO’s conversations with sales staff:

The FDA does not permit sellers to make claims that their products can treat, prevent, or cure specific diseases. The GAO found exactly that … sellers claiming “dietary supplements could treat, prevent, or cure conditions” such as diabetes, cancer, cardiovascular disease, high cholesterol, and Alzheimer’s disease.

GAO had a lab test 40 popular herbal supplements for the presence of lead, arsenic, mercury, cadmium, and pesticides.  They found:

GAO found trace amounts of at least one potentially hazardous contaminant in 37 of the 40 herbal dietary supplement products tested. … All 37 supplements tested positive for trace amounts of lead; of those, 32 also contained mercury, 28 cadmium, 21 arsenic, and 18 residues from at least one pesticide.”

Not to worry. The government can raise limits of allowable contaminants so that products may continue to be sold. That’s what they did when fish was found to contain too much mercury:

“The current US do-not-sell limit is 1.0 ppm – that’s 1.0 parts of mercury per million parts of fish tissue. The limit was 0.50 ppm in the 1970’s, during which time canned tuna was found to surpass that amount. Subsequently, 12 million cans of tuna were recalled – and the limit was quickly raised. Canada’s limit is still 0.50 ppm.”

Here are some heavy metals and pesticides GAO found in their samples. These are partial lists; there is more in their report:

SupplementsContaminated2

SupplementsContaminated3

It is more likely than not that your supplements contain pesticides and contaminants. No regulatory body is testing these things for safety (contaminants) or efficacy (does it do what the bottle says it will do).

People go out of their way to buy organic food because they say it doesn’t contain pesticides. Yet they will buy dietary supplements which are concentrated sources of pesticides and other toxins.

Some say government should not engage in public health activities. That government should not monitor foods and supplements for pesticides, heavy metals, petroleum derivatives, endocrine disruptors, pathogenic organisms, and other harmful substances. That businesses should be able to sell anything they please with no inspections, no accountability, and freedom from being sued. That man’s innate sense of good will ultimately prevail. But in the back of my mind, I hear George Carlin saying:

“[Big, wealthy businesses] don’t care about you … at all … at all … at all.”

Unsafe Supplements And The Revolving Door Between The Supplement Industry And FDA

Are you taking a multivitamin that contains selenium? How do you know that the amount stated on the label is what is in the pill? Do you just trust? No government body, including the FDA, tests that supplements are safe and effective. And in 2008, more than 200 people suffered selenium poisoning from a brand of multivitamin that was subsequently recalled by the manufacturer.

From: Selenium Toxicity from a Misformulated Dietary Supplement, Adverse Health Effects, and the Temporal Response in the Nail Biologic Monitor, Nutrients, April 2013:

“The median selenium (Se) exposure … ranged from 669,570 to 965,520 μg over an approximate 30 day period, which exceeds the RDA for Se by a factor of 300 to 585 leading to selenosis symptoms and adverse health effects, some debilitating, that persist 2.5 years.”

“Let the Buyer Beware” is no longer an adequate national policy to regulate the booming dietary supplement enterprise.”

There was a great commentary by Dr. Pieter Cohen a few weeks ago on just this topic:

Hazards of Hindsight — Monitoring the Safety of Nutritional Supplements, New England Journal of Medicine (NEJM), 4 April 2014

Cohen tells of a popular supplement, OxyElite Pro, that caused 97 cases of severe hepatitis, 47 hospitalizations, three liver transplants, and one death. FDA didn’t even know about the hepatitis cases until 4 months after they came to light.

“Unlike prescription medications, supplements do not require premarketing approval before they reach store shelves. Under the Dietary Supplement Health and Education Act of 1994, anything labeled as a dietary supplement is assumed to be safe until proven otherwise. The FDA is charged with the unenviable task of identifying and removing dangerous supplements only after they have caused harm.”

Cohen notes that a bill in a Senate committee, the Dietary Supplement Labeling Act, would require supplement manufacturers to provide a bit more safety information, such as listing a supplement’s known side effects. That could happen.  Here’s an example:

SupplementSideEffects

Note that prostate cancer is listed as a side effect of taking vitamin E, which I discussed here.

But he really wants to see:

“Every supplement ingredient should undergo rigorous safety testing before marketing. Until that happens, consumers and physicians cannot be assured that the pills, powders, and potions labeled as dietary supplements are safe for human consumption.”

I doubt that will happen. This is why…

The New York Times covered Cohen’s article this morning: Why Dangerous Supplements Linger on Store Shelves

Now, watch this. Are you ready?

Cohen said, in a prestigious, peer-reviewed journal, on April 4, that the FDA wasn’t banning bad products in a timely fashion, if at all. FDA’s Director of Dietary Supplements, Daniel Fabricant, said:

“I certainly understand and share Dr. Cohen’s concern, but I do think the system has been useful and successful and instrumental in the agency taking action against products that were unsafe.”

Four days after Cohen’s critical article, the FDA announced that Fabricant was leaving the agency. No replacement was named.  Fabricant was a top executive for a dietary supplement trade group, the Natural Products Association, before he joined FDA in 2011. He will be returning to that trade group as its CEO.

This is called a revolving door between industry and government. It is how industry manipulates government. While at the FDA, industry-friendly Fabricant was involved in drafting guidance for “New Dietary Ingredients” and “Good Manufacturing Practices.”  And Fabricant will return to his industry with a deeper understanding of how government operates, thanks to his stint as an FDA director.

As long as a revolving door is in place, we will probably never see premarket safety and efficacy testing of dietary supplements.

This is an example of how the United States is earning its oligarchy badge.

Folic Acid Supplements Increase The Risk For Cancer, Especially Lung Cancer

FolicAcidFortification2I’m going to couple my last post (Taking Vitamin E Supplements Increases The Risk For Prostate Cancer) with this post about the link between folic acid and cancer. Because people are also still taking folic acid supplements in this country (take a look at your multivitamin), even though this combined analysis of 2 large, randomized, double-blind, placebo-controlled trials (the gold standard of scientific investigation):

Cancer Incidence And Mortality After Treatment With Folic Acid And Vitamin B12, Journal of the American Medical Association, November 2009

… found:

“Conclusion: Treatment with folic acid plus vitamin B12 was associated with increased cancer outcomes and all-cause mortality in patients with ischemic heart disease in Norway, where there is no folic acid fortification of foods.”

There was a 21% increased risk for getting cancer and a 38% increased risk of dying from cancer. Lung cancers dominated. Patients who experienced increased risk were taking 800 micrograms/day (mcg/d) of folic acid.1 (They also took 400 mcg/d of vitamin B12 and/or 40 mg/d of vitamin B6.)

The recommended allowance (or DRI: Dietary Reference Intake) for folic acid in this country is 400 mcg/d. So they were taking twice the DRI. Yet they fell short of the tolerable upper intake of 1000 mcg/d.

In our body, folate is used in DNA replication; it’s needed for cell growth and repair. Cancer cells also use it for growth. “High doses of folic acid may speed cell division and increase tumor progression in preneoplastic lesions.”

Two items of note:

  1. Participants in these studies lived in Norway where there is no fortification of foods with folic acid. The US embarked on a mandatory fortification program in 1998 – flour and grain products here contain added folic acid. That’s in addition to the folic acid added to our breakfast cereals, often 400 mcg/serving. (A bowl of cereal and a typical vitamin pill can easily put you at 800 mcg. Eat anything made with folic-acid-fortified-flour and you’ll surpass their intake.)
  2. One mechanism put forth for the increased cancer rates was reduced activity of our immune system’s natural killer cells in the presence of high levels of folic acid.2 Coincidentally, high intakes of omega-3 (about 1 gram/day) were also seen to reduce the amount and activity of natural killer cells.

Taking vitamins is not as innocent as supplement manufacturers lead us to believe. But people still think a vitamin pill is harmless.

1 Folate found naturally in food hasn’t been shown to be harmful. Green leafy vegetables are a great source.
2 Unmetabolized Folic Acid in Plasma Is Associated with Reduced Natural Killer Cell Cytotoxicity among Postmenopausal Women, Journal of Nutrition, 2006

Taking Vitamin E Supplements Increases The Risk For Prostate Cancer

Note that this Vitamin E, the same type and strength used in this study that found taking it increased the risk for prostate cancer, is USP Verified. Less than 1% of dietary supplements are USP Verified. USP does not, however, vouch for a product’s safety or efficacy. The FDA doesn’t either. No regulatory body does.

People are still taking vitamin E supplements, either separately or as part of a multivitamin pill. They should know that this landmark study:

Vitamin E and the Risk of Prostate Cancer, The Selenium and Vitamin E Cancer Prevention Trial (SELECT), Journal of the American Medical Association, 12 October 2011

… found:

“Conclusion: Dietary supplementation with vitamin E significantly increased the risk of prostate cancer among healthy men.”

The study was big (35,533 men from 427 study sites in the United States, Canada, and Puerto Rico), and long (7 years: 2004 to 2011). It was designed to test whether taking vitamin E or selenium would prevent prostate cancer. Epidemiological studies suggested they might. Neither were found to prevent prostate cancer. And in the case of vitamin E, just 400 IU’s/day were found, to many people’s surprise, to increase the risk. The increased risk was statistically significant.

“Results: This report includes 54 464 additional person-years of follow-up and 521 additional cases of prostate cancer since the primary report. Compared with the placebo (referent group) in which 529 men developed prostate cancer, 620 men in the vitamin E group developed prostate cancer (hazard ratio [HR], 1.17; 99% CI, 1.004-1.36, P = .008).”

“The risk of prostate cancer at 7 years of median follow-up was increased by 17% in men randomized to supplementation with vitamin E alone, a difference that started to appear about 3 years after randomization. … The increased rate of prostate cancer in the vitamin E group was seen as early as 2006 and continued until the present analysis (HRs ranged from 1.12 to 1.17) suggesting that the current results are not an outlier observation due to multiple looks at the data.

Despite the lack of a mechanistic explanation, the findings show that vitamin E supplementation in the general population of healthy men significantly increases the risk of being diagnosed with prostate cancer.

This study only looked at prostate cancer. It couldn’t comment on other cancers. And it also couldn’t say if lesser doses were safe. 400 IU’s raises the risk for prostate cancer, but does 200 IU’s? 50 IUs? The following excerpt is going to hinder future studies that try to answer those questions:

“Furthermore, the fact that the increased risk of prostate cancer in the vitamin E group of participants in SELECT was only apparent after extended follow-up (allowing for additional events) suggests that health effects from these agents may continue even after the intervention is stopped.”

You could draw many assumptions from a study like this, and none of them, given this data, would support taking vitamin E supplements.

But this doesn’t stop people from taking vitamin E, “just to be safe” or “as an insurance policy against when I don’t eat right” or “to top off” their diet.  They say taking vitamins doesn’t do any harm and could help.  How do they know there is no harm?  And where is the evidence that these pills help us live longer? Or in better health?

I just came from Dr. Weil’s site, where he continues to advise taking 400 to 800 IUs vitamin E daily and says (as of 29 October 2012, a year after this study was published), in response to the question, “Are there any risks associated with too much vitamin E?” … “Except for an anticoagulant effect, vitamin E has no known toxicity or side effects.”

See my related post: Folic Acid Supplements Increase The Risk For Cancer, Especially Lung Cancer