UPDATE

ANH Press Release: 3 March 2009, New science supports high dose supplementation 

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It’s not often you pick up a single edition of a mainstream scientific journal—the places where scientists so often validate drugs while canning nutrients—that you find three positive studies concerning nutrients. Well, Volume 169 (no. 4) of the Archives of Internal Medicine, issued on 23 February, is one such journal.

The big message coming out of all three studies is that the dose of the nutrient is all-important. The part that lots of zealous regulators, doctors and Pharma reps won't want to hear is: high doses deliver results, low doses don't.

We recently reported the International Society for Orthomolecular Medicine making this exact point. Check out our story on this: Vitamins, it's dose that does it, says ISOM from 3 February 2009.

So, what’s the good news?

Let’s look at each study briefly and offer some key take-home points.

Study 1: The Women’s Antioxidant and Folic Acid Cardiovascular Study

(Christen W, Glynn R, Chew E, et al., Archives of Internal Medicine, 2009; 169(4): 335-341).  

• This study is part of the very large series of trials that have been ongoing and coordinated through Brigham and Women’s Hospital, Harvard Medical School.
• A placebo-controlled randomised controlled trial (RCT) on 5442 over-40s female health care professionals who either had heart disease or were at high risk of it. They took 3 high dose—and the issue of dosage is perhaps the most important aspect of this study—B vitamins daily for an average of about 7 years, these being folic acid (2.5 mg/d), pyridoxine hydrochloride (vitamin B6) (50 mg/d), and cyanocobalamin (vitamin B12) (1 mg/d).
• The study showed not only an over 18% reduction in the amino acid homocysteine, but a highly significant 35 to 40% reduction in age-related macular degeneration (AMD). What’s so interesting about these results is they’re associated with high dose supplementation. The intake levels are way above the maximum levels that Europeans will soon be forced to accept. More on this later.
• The role of vitamins and the mineral zinc in reducing the risk of AMD had previously been demonstrated in the AREDS study (Age-related Eye Disease Study) of 2001, where a 19% reduction in AMD was shown in the group taking a combination of vitamin C (500 mg/d), vitamin E (400IU/d), beta-carotene (15 mg/d), and zinc (80 mg/d) (Arch Ophthalmol. 2001; 119(10):1417-36). But here, only the zinc level can properly be regarded as ‘high dose’.
• Lutein, zeaxanthin, zinc, vitamin C and other nutrients were not included in the Women’s Antioxidant Study, despite evidence of their benefit for reducing the risk of AMD. Could an even better result have been obtained if the combination had been ‘optimised’ using available knowledge of the role of nutrients in reducing AMD?
• But 35-40% benefit isn’t a bad result for a bunch of cheap patent-free nutrients. Had this been a drug, we would no doubt have seen the results plastered over the front pages of major newspapers around the world and the drug pushed into the hands of every general practitioner in the western world.

Study 2: The effects of calcium intake from supplements and dairy on cancer risk

(Park Y, Leitzmann M, Subar A, et al. Dairy Food, Calcium and Risk of Cancer in the NIH-AARP Diet and Health Study. Archives of Internal Medicine, 2009; 169 (4):391-401).

• In this study, 36,965 men and 16,605 women with cancer (at various sites in the body)  completed a questionnaire  on their diet and supplementation habits. In both men and women, there was a clear relationship between increasing calcium intakes from dairy and supplements being correlated with lower incidences of colorectal cancer. Risk of these cancers was reduced by around 15% in men and 25% in women. In both genders, colorectal cancer rates were lower in those taking calcium supplements.
• In women, the relationship was clearest, with calcium intake from these sources being linked to a decrease in all types of cancer, although there was not benefit gained when calcium intakes exceeded 1300 mg/d. 
• But of course, there are numerous other nutrients that might play a role in this. Let’s not forget the key role of magnesium and vitamin D, as well as whey proteins (immunoglobulins) in dairy.

Study 3: Vitamin D and Upper Respiratory Tract Infections

(Ginde A, Mansbach J, Camargo C. Association Between Serum 25-Hydroxyvitamin D Level and Upper Respiratory Tract Infection in the Third National Health and Nutrition Examination Survey. Archives of Internal Medicine, 2009; 169 (4):384-390).

• The three authors of this study looked at the relationship between serum (blood) vitamin D levels and the frequency of recently reported upper respiratory tract infections (URTIs).
• The study found an association between increasing serum levels and decreasing URTIs. The rates of URTIs went from 24% in those with a low serum vitamin D level, to 20% in the intermediate group and 17% in the highest vitamin D group — a 29% relative reduction.
• Vitamin D is primarily produced by the body following sunlight exposure and is generally present in low levels in the diet. Vitamin D3 supplements are a particularly useful way of supplementing the body with vitamin D during the winter months. In the summer, 85% body exposure for around 15 minutes is all that’s required to get the body to produce vitamin D at highest rate, which equates to an intake of at least 10,000IU/day.
• Vitamin D’s role in supporting the immune system has been well demonstrated. The vitamin has been shown to help both the side of the immune system that controls infections as well as that responsible for managing inflammatory responses. 
• This study adds to the already remarkable literature on the benefits of vitamin D, a nutrient that has developed almost superhero status in nutritional circles!

Conclusions

There are two overwhelming conclusions from these studies:

a) whether you're looking at the B vitamins in the AMD study, the association between calcium intake and cancer or that of vitamin D in reducing upper respiratory tract infections, it was the high doses that delivered the best results.

b) the dosages to which European regulators want to limit us are far below those that delivered the best results in these studies. For example, in the AMD study, the folic acid level was 12.5 times over the European RDA, while that of vitamin B6 was 25 times over and  of vitamin B12 1000 times over. And by the way, no adverse effects were reported (are you really surprised.....?!)

While these studies point to the importance of high dose supplementation, it’s an irony that we are in the midst of a battle to save high dose supplements from restrictions by over-zealous regulators. Find out more in our Health Choice campaign.