Vitamin D Supplements Do Not Reduce Falls, Fractures or Improve Bone Density

Much has been written about the benefits of supplementing Vitamin D in patients. The World Health Organization sets its normal blood level at 20 while in North America it is listed at over 30. Under normal circumstances when your skin is exposed to sunlight your kidneys produce adequate amounts of Vitamin D.

Over the last few years low vitamin D levels have been associated with acute illness and flare-ups of chronic illness. The Vitamin D level is now the most ordered test in the Medicare system and at extraordinary expense. Supplementing Vitamin D has become a major industry unto itself.

The October 4th edition of the Lancet Diabetes and Endocrinology contained an article written by New Zealand researchers that looked at 81 randomized research trials containing almost 54 thousand participants. “In the pooled analyses, researchers found that Vitamin D Supplementation did not reduce total fracture, hip fracture, or falls – even in trials in which participants took doses greater than 800 IU per day.” Vitamin D supplementation did not improve bone mineral density at any site studied (lumbar spine, hip, femoral neck, forearm or total body).

They concluded that there is little justification for the use of Vitamin D Supplements to maintain or improve musculoskeletal health, and clinical guidelines should reflect these findings.

Does Curcumin Use Help with Cognitive Dysfunction?

Recently, more and more patients have been adding curcumin or turmeric to their cooking to help with their memory. Curcumin is a metabolite of Turmeric and has been available in health food stores for years.

A study a few years back on Alzheimer’s patients published by J. Ringman and Associates showed no benefit in slowing the development of symptoms and no improvement in symptoms when supplied with curcumin. When they looked closely at their study, and analyzed the participant’s blood, they found that curcumin was not absorbed and never really entered the bloodstream.

Last month a study was published in the American Journal of Geriatric Psychiatry by Dr. Gary Small and colleagues. They looked at 40 patients with mild memory complaints aged 50 – 90.  Some were administered a placebo and others were administered nanoparticles of curcumin in a product called “Theracumin”. The participants were randomized and blinded to the product they were testing. The study designers felt the nanoparticles would be absorbed better than other products and would actually test whether this substance was helpful or not. At 18 months, memory improved in patients taking the nanoparticles of curcumin and they had less amyloid deposition in areas it usually found relating to Alzheimers Disease.

Robert Isaacson MD, the director of the Alzheimer’s Prevention Clinic at Weil Cornell Medicine and New York- Presbyterian, has been suggesting his patients cook with curcumin for years. Until the development of the Theracumin nanoparticles, cooking with curcumin was the best way to have it absorbed after ingestion. There is now some evidence to suggest that curcumin, in this specific nanoparticle form, may play a role in both the risk reduction and potential therapeutic management of Alzheimers Disease.

Fish, Fish Oils and Cardiovascular Disease

Years ago the scientific researcher responsible for the promotion of fish oils as an antioxidant and protector against vascular disease recommended we all eat two fleshy fish meals of cold water fish a week. He continued to endorse this dietary addition and included canned tuna fish and canned salmon in the types of fish that produced this positive effect.

Over the years I heard him lecture at a large annual medical conference held in Broward County and he fretted about the growth of the supplement industry encouraging taking fish oils rather than eating fish. He worried about the warnings against eating all fish to women of child bearing age because of the fear of heavy metal contamination and knew that the fish oils and omega 3 Fatty Acids played a developmental role in a growing fetus and child.

I then attended lectures, in particular one sponsored by the Cleveland Clinic, during which they promoted Krill oil as the chosen form of fish oil supplements because it remained liquid and viscous at body temperature of 98.6 while others solidified. I listened to this debate only to hear the father of the science speak again and this time advocate that one or two fleshy fish meals a month was adequate to obtain the protective effect of Omega 3 Fatty acids. He felt that the supplements did not actually provide a protective effect as eating real fish did. Since I love to eat fresh fish I had no problem with this message but others are not comfortable buying and preparing fish at home or eating it at a restaurant. Supplements to them were the answer.

Steve Kopecky, M.D. examined the question in an article published in JAMA Cardiology this week. He looked at 77,917 high risk individuals already diagnosed with coronary artery disease and vascular disease who were taking supplements to prevent a second event. His study concluded that taking these omega 3 supplements had no effect on the prevention of recurrent cardiovascular events. The study did not discuss primary prevention for those who have not yet had a vascular illness or event.

Once again it seems that eating fish in moderation, like most anything, is the best choice. I will continue to eat my fresh fish meals one or two times per week, not necessarily for the health benefit but because I enjoy eating fresh fish.

I advise those worried about preventing primary or secondary heart and vascular disease to find a form of fish they can enjoy if they want this benefit. If you really wish to reduce your risk of a cardiovascular event; I suggest you stop smoking, control your blood pressure and lipid profile, stay active and eat those fresh fish meals.

Vitamin D in Senior Citizens: How Much is Enough?

Vitamin D levels are the most popular blood test being billed to CMS Medicare and private insurers. The World Health Organization considers 20 ng/ml to be a normal level of 25-hydroxyvitamin D which contrasts with 30ng/ml in the USA. Vitamin D is made by the kidney when our limbs get exposed to sufficient sun light. It is low in severe and chronic states. Supplementing Vitamin D does not improve the illness except possibly in multiple sclerosis but can return the serum level to normal.

Experts in fall prevention hoped that supplying adequate vitamin D will preserve muscle function and reduce falling. About one in three elderly experience a fall annually with one fracture per five falls. In the USA this amounts to 250,000 hospital admissions for hip fracture each year. The research hope was that by raising the Vitamin D level to 30 we would reduce falls and fractures.  Unfortunately individuals 70 years or older who took 2000IU of Vitamin D a day or 60,000units per month, had more falls and a higher risk of falls than seniors who had lower serum levels and less supplementation. Their muscle function improved with higher dose vitamin D but so did the falls.

The Institute of Medicine, an independent US advisory panel advises taking 800 IU per day or 24,000 IU per month with a goal of a serum level of 21-30 and less frequent Vitamin D level monitoring.

Fish Oils in Osteoarthritis – Low Dose vs. High Dose

Using the common sense approach that if a little bit is good then more is better in the treatment of “rheumatism” Catherine Hill, M.D., of the University of Adelaide in Australia and colleagues looked at the effect of taking low dose fish oil supplements versus high dose fish oil supplements. When one looks at the adult population of Australia, one third of them take fish oil supplements and had within a month of this study. The typical dose is one ml of fish oil per day. Experts say the dose for anti-inflammatory effect for arthritis is considerably higher at 2.7 gram or 10 ml per day. Dr Hill’s theory was that high dose fish oil for symptomatic and structural outcomes in people with knee osteoarthritis was better.

She enrolled 202 symptomatic patients in a double blind study. High dose group patients received 4.5 g EPA/HPA per day. The low dose group were given a blended of fish oil containing 0.45 g EPA /DHA per day in combination with Sunola oil. Both supplements were flavored with citrus oil.

All patients received a baseline MRI of the knee at inception of the study and at two years. The patients mean age was 61 years and body mass index was 29kg/meter squared. Both groups showed x-ray evidence of arthritis in the knee at inception and both groups were allowed to take non-steroidal anti-inflammatory medications and acetaminophen for arthritic pain during the course of the study.

At two years there was no difference in the MRI findings or cartilage volume loss between the high dose and low dose groups. Each group took similar amounts of NSAIDs and acetaminophen for pain on a regular basis. The high dose had no benefit over the low dose.

The researchers concluded that there was no benefit in their study to high dose versus low dose fish oil supplementation for arthritis. They reasoned that since patients in the study were permitted to take additional fish oils on their own during the study this may have altered the findings. The researchers additionally had little control over how much fish the participants ate.

In reviewing the data it seems to indicate that fish oil played a minor role in slowing down arthritis in the knee joint. Low dosage had as good of an effect as high dosage but the studies lack of a true control group who did not take fish oil at all made the conclusions hard to accept.

I will suggest to my patients that they continue to eat two fleshy fish meals per week to get their fish oils for arthritis and cardiovascular protection, rather than purchasing and taking low dose or high dose fish oil supplements.

What Is In Those Supplements?

VitaminsThe Attorney General of the State of New York charged four national retailers on Monday, February 2nd  of selling dietary supplements that were “ fraudulent and in many cases contaminated with unlisted ingredients.” His office said they had run tests on popular store brands of herbal supplements at the retailers – Walgreens, Walmart, Target and GNC and found that out of five products tested, four contained none of supplements listed on the label. At GNC they found that five of six samples from its “Herbal Plus “brand were either “unrecognizable or a substance other than what they claimed to be.” They analyzed Ginkgo Biloba, St. John’s Wort, Ginseng, Echinacea, Saw Palmetto, Garlic and Valerian Root.

For many years now health care advocates have encouraged the Federal government to establish a safety monitoring system for the multibillion dollar vitamin, mineral, herb and supplement product market. Many health care providers question the safety and efficacy of these products to begin with since there are few if any well designed double blinded controlled studies which look at their overall risks and benefits. To now find out that the bottles do not even contain product raises further questions about their efficacy and safety. The American College of Nephrology has been trying to educate the public to the harmful contaminants they have found in many over the counter supplements leading to renal failure and problems in children. Most of these poisons and heavy metal contaminants however, came from products produced overseas.

The time to set up a Federal watchdog on these products is long overdue. The National Institute of Health Division of Alternative and Complimentary Medicine has always taken the position that if products results are positive and reproducible in legitimate studies then the product is not an alternative treatment. That feeling is still shared by me but it does require the product to be in the container you purchase free of harmful contaminants.

Are Older Women Receiving Too Much Calcium?

CalciumThe June issue of Menopause, a peer reviewed medical journal, carried an original research article by Margery Gass, MD and colleagues which indicated that older women are taking too much Vitamin D and Calcium. She conducted a randomized and placebo controlled trial of 163 women with low Vitamin D levels. The age range of the study group was 57 to 90. They were given Vitamin D and Calcium citrate tablets to reach the recommended daily amount of 400 to 4800 IU per day of Vitamin D and 1200 mg of calcium per day. Follow-up lab studies revealed that almost 10% of the women developed elevated blood calcium levels. More disturbing was the fact that 31% developed elevated levels of calcium in their urine predisposing them to kidney stones.

The lead author suggested that every patient calculate how much calcium they are getting daily in their normal diet before supplementing it with extra calcium. Her group pointed out the benefits of clinicians periodically measuring patients 24 hour urine calcium level. Those with a level > 132 mg were at much higher risk of developing hypercalcemia and its complications and need to reduce their supplemental calcium intake. We will begin suggesting 24 hour urine collection in our patients in the near future.

Supplement Toxicity on the Rise

VitaminsIn a report in MedPage Today, the medical newsletter of the University of Pennsylvania School of Medicine, researchers attending the meeting of the American Association of the Study of Liver Diseases reported a striking increase in the number of severe liver injuries reported in supplements between the years 2004 and 2012. They reported the number of cases increased from 7 – 20% and blamed the vast proportion of those cases on dietary and herbal supplements.  Particularly disturbing was the number of injuries in young people involved in bodybuilding.

Mary Rinella, MD of Northwestern Memorial Hospital in Chicago moderated a discussion group on the topic and mentioned what a large problem it is; “It’s made worse by the popular belief that such supplements are harmless, which leads patients to omit mentioning them when they are in a clinic or doctor’s office.”  She went on to say that, “We don’t know what’s in the products or even what’s in the bottle.” Rinella said.  “Dietary and herbal supplements are not considered drugs and so escape oversight by the FDA.”

Warren Kupin, MD, FACP of the University of Miami Miller School of Medicine division of nephrology delivered a similar message on the epidemic of kidney disease in young adults being caused by the contents of common herbs and supplements sold on our shelves with pleasant healthful sounding names. He raised the red flag on products produced in India and Asia or products containing materials from those areas which contain high levels of heavy metals such as mercury, cadmium, arsenic and others. The target market is young women of child bearing age and they expose their partners and children to these products.  He took a commonly sold supplement, opened the bottle and said that the aroma escaping contained so many heavy metals that if this was produced in a US factory OSHA would require the workers to be wearing respirators in that type of toxic environment.

Consumers need to read labels and ask questions of their doctors before they add an herb or supplement to their daily regimen.  Women of child bearing age need to be especially vigilant and discuss these supplements with their obstetricians and pediatricians before considering ingesting them. The National Institute of Health maintains a very objective website on alternative and complimentary medications at nccam.nih.gov/health/whatiscam that is a great resource and location of factual material.   

I always suggest that when you visit your doctor you bring all your medications, vitamins, minerals, herbs and supplements in a plastic bag with you so that the doctor can read the labels with you.  Accepting the advice you receive on the Internet or from the sales personnel at a vitamin and mineral store is not the most accurate way to learn the truth.  The public is injuring and maiming themselves by consuming too much of the wrong things and there is little or no government oversight and regulation of these products. Protect yourself and ask your doctor for assistance!

 

Multivitamins in the Prevention of Cancer in Men

Vitamin, mineral and supplement use in the United States is a multi-billion dollar industry. Despite many testimonials extolling the benefits of supplemental vitamins, there has been very little research that actually provides evidence that these supplements are beneficial. However, there is abundant evidence that over consumption of the fat soluble vitamins, A, E, D and K results in accumulation of the substances and eventual toxicity.  The 2010 Dietary Guidelines for Americans says, “For the general, healthy population, there is no evidence to support a recommendation for the uses of multivitamin or mineral supplements in the primary prevention of chronic disease.”

The Physicians Health Study II (PHS II), a randomized controlled study, followed 14,641 male U.S. patients initially aged 50 or older for a median of 11.2 years. Their results showed that “daily multivitamin supplementation modestly but significantly reduced the risk of total cancer.”  The study could not clarify or specifically define which nutrient or nutrients in their supplemental multivitamin were responsible for the effect in reducing cancer.

The study used the multivitamin Centrum Silver.  However, it did not examine the effect of multivitamins in women.  Nor, did it did allow participants to consume additional vitamins, minerals, supplements or herbs.

The message to individuals is clear. Eat a healthy and balanced diet that is prepared in a manner that does not destroy the nutrients.  A multivitamin such as Centrum Silver will reduce your risk of cancer minimally. There is no proof that taking additional products with the multivitamin will have a more positive effect.

The Calcium – Vitamin D Supplementation Picture Gets More Confusing

As a geriatrician who believes strongly in prevention, my perspective is that the recent high volume of research on healthy aging, chronic disease and its association with Vitamin D and Calcium supplementation has done nothing but confuse the picture for us all. I have always been an advocate of healthy eating – a balanced diet that is prepared in a manner that retains and promotes the absorption of the foods nutrients. Also, I have supported the recommendations of blue ribbon panels to supplement the diets of women of child bearing age, peri-menopausal women and post menopausal women with 1200- 1500 mg of calcium per day in addition to dietary calcium to promote healthy bones.

I have read extensively about the lower measured values of Vitamin D in men and women who are ill and have many different types of acute and chronic diseases. I have not truly accepted the idea that raising their measured serum level of Vitamin D with pill supplements did anything to improve the disease state even if we did raise the measured serum Vitamin D level. I have been amazed by experts in Europe and Asia and in the World Health Organization setting a normal lower value of measured Vitamin D level at 20 while in the USA it is 28.  I am not convinced that healthy adults with healthy kidneys cannot get adequate Vitamin D levels by 10 minutes of sun exposure a few times per week in increments which will not dramatically increase the risk of lethal skin cancers.

This was made all the more confusing by the United States Preventive Services Task Force suggesting  that Vitamin D supplements reduce the risk for older people prone to falls and this month announcing that “there is no value for postmenopausal women using supplements up to 400 IU of Vitamin D and 1000 mg of calcium daily.”  This latest ruling was based on data which showed that at 400 IU of Vitamin D and 1000 mg of Calcium daily there was no effect on the incidence of osteoporotic fractures.

Much of the data used to reach this conclusion came from the Women’s Health Initiative Studies of more than 36,000 postmenopausal women.  The USPTF noted that at this dose of Vitamin D and Calcium there was a clear increase in kidney stones which they considered a harmful effect.  At the same time as this data was being discussed, the impartial Institute of Medicine (IOM) presented suggestions and data that Vitamin D at 600 IU daily plus 1200 mg of calcium per day prevented fractures in postmenopausal women.

For my postmenopausal patients I will continue to suggest they supplement their diets with 1200 mg of calcium per day as per the IOM suggestions unless they are prone to kidney stones. They will need to stay well hydrated while I ask them to take a daily 30 minute walk exposing their arms and legs to the sun for at least 10 minutes to allow their healthy kidneys to manufacture Vitamin D.