Q: You recently wrote about Alzheimer’s and the vitamin E perhaps playing a role in helping the disorder. Now I just heard on my television that multiple sclerosis might be helped by vitamin D. How come these conditions and others have never been researched before for what might be such simple remedies to such disastrous disorders?
A: Clinical trials or studies are ongoing in countless hospitals and medical facilities across our entire country and abroad for almost every disorder known. They are essentially research studies designed to provide answers on drugs, vaccines, and treatments that are conducted only after sufficient information has been gathered that will satisfy ethics committees and health authorities in the country where approval is being sought. Each trial has a protocol or plan of action as to what will be done, how it will be accomplished, and why each step is considered necessary. And, there are specific rules as to those individuals accepted to be a part of the studies. Some trials may require individuals who actually have the specific disease or disorder, others may require healthy people, and still others may simply want willing participants who don’t fit into either of these categories. In our country, an independent committee of physicians and statisticians must approve and monitor the procedures used, essentially to be assured the risks are minimal and are worth any potential benefits that may or may not be derived.
Those individuals selected will enter what is called a small pilot program that may ultimately develop into a larger scale study. As data is collected, the number of “patients” in the study will generally increase. A full series of trials may cost hundreds of millions of dollars, a fee which is borne by a pharmaceutical company, medical device company, biotechnical firm, or governmental agency.
In the United States, our senior citizens constitute less than 15% of our population, yet they consume over one third of prescribed drugs; therefore, they may often be excluded from such trials simply because of the drugs they are on on a regular basis and because of health issues they may have which may interfere with the results. Individuals with unrelated medical conditions may also be excluded from participating in the trials. Most clinical trials today are done to evaluate new drugs, medical devices, psychological therapies, or biologics.
Trials are not new – one famous one was James Lind’s demonstration in 1747 which involved citrus fruits to cure scurvy on afflicted sailors. The result of his trial was that those sailors with scurvy recovered in six days, as opposed to those who weren’t treated with an acidic substance. From there, the world of clinical trials was off and running. Today things are more sophisticated, to the degree that the National Institutes of Health organizes trials by type – from prevention, screening, diagnostics, treatment, quality of life, to expanded use trials and more.
The trial to which you refer was published on line January 20th in JAMA Neurology. It indicated vitamin D may slow the progression of multiple sclerosis and may also reduce harmful brain activity. Some experts indicate it’s too soon to recommend giving D supplements to individuals with central nervous system disorders, and the correct dose of the vitamin given early in the course of the disease isn’t known. Others, such as Dr. Alberto Ascherio, a professor of epidemiology and nutrition at the Harvard School of Public Health is convinced that the “sunshine vitamin” can be of great benefit to MS patients.
In the study, D levels at the time of the initial MS symptoms predicted the progression of the disease for the following five years. Those with lower D levels (below 50 nanomoles per liter) were more likely to develop new brain lesions and had a poorer prognosis than those with higher levels. He felt the latter should be corrected by D supplementation. Another assistant professor at John Hopkins in Baltimore countered that no study has yet established whether taking the supplement helps reduce new symptoms and disability from occurring.
Vitamin D is obtained from sunlight, fortified dairy products, foods such as fish that contain omega-3 oils, and through oral supplements sold over-the-counter. While D appears to have positive qualities, this and all supplements and medication may have negative effects we are unaware of, and each of us may react differently.
Without all of the questions answered and despite the glowing reports of some researchers, those patients with MS should consult their attending physician before making any commitment of supplemental D.
