SCARBOROUGH — The Maine Medical Center Research Institute is recruiting hundreds of Mainers to take a Vitamin D pill or a placebo as part of a massive, $40 million National Institutes of Health study on whether Vitamin D can prevent Type 2 diabetes.
Vitamin D’s potential power to do that is a much-debated topic among medical researchers.
“Right now, it’s magical thinking,” said Dr. Clifford Rosen, a senior scientist at the research institute who has participated in debates all over the country regarding Vitamin D, playing the role of the skeptic. “But I always lose the debates, because people want to believe Vitamin D will help them.”
Rosen’s participation on a national committee about the topic helped lead to Maine being one of the 20 sites chosen for the nationwide study, officials said.
The Scarborough research institute will need 600 to 700 people possibly at risk of becoming diabetic to agree to be part of the NIH study. After pre-screening, about 150 will be selected to participate, with half given a placebo and the other half a 4,000-international unit Vitamin D pill. Maine Med is currently accepting people interested in participating in the study, and is now looking to ramp up the number of those willing to have their blood drawn and take a pill.
Since the mid-1990s, the percentage of those with diabetes in Maine has doubled, according to the U.S. Centers for Disease Control and Prevention. A 2011 report by the Maine Center for Disease Control and Prevention said about 90,000 adult Mainers are diagnosed with Type 1 or Type 2 diabetes. Type 2 is the more common form. Maine has about 1.3 million residents.
Nationally, thousands of people will participate in the research – called the “D2d” clinical trial and led by Tufts Medical Center in Boston.
The human clinical trial at the Scarborough research institute will be among the largest ever to be conducted in Maine, hospital officials said. Maine Med will receive $1.6 million to conduct the study, and will be part of the research team to evaluate the results.
“Maine doesn’t have these kinds of large medical trials very often, and if we do well, we can hopefully get more of them,” said Dr. Irwin Brodsky, principal investigator at the Scarborough institute. “Then we can attract more scientists to do more clinical research in Maine, once we’ve proven that we can do this. We’re trying to carry the banner.”
It will take more than a year to complete the clinical trial, and then participants will be screened every six months to see if they went from being at risk of diabetes to having the disease. It’s not certain how long officials will be studying the results of the trial, but it will be for at least a few years, Brodsky said.
Vitamin D pills have become a hot topic in medicine in recent years, with many physicians prescribing them to patients for pre-diabetics or those in the early stages of Type 2 diabetes, Brodsky said, or for other reasons, such as Vitamin D deficiency.
“The Vitamin D industry has turned from a few million dollars into a billion-dollar industry. Everybody is taking these pills, it seems,” Brodsky said.
He said Vitamin D’s origins go back to the dawn of life on Earth. “Vitamin D is this primordial molecule that was floating in the soup of creation,” Brodsky said.
For diabetics, the theory is that Vitamin D helps the body produce insulin. In diabetics, the body has a harder time producing insulin, and the body’s ability to produce it degrades over time, eventually requiring insulin shots.
“I thought this was a great opportunity to fully answer the question, ‘Is Vitamin D helpful to people at risk of diabetes?’ ” Brodsky said. “I have no preconceived notions about whether it would work. The hope is that it will help everybody.”
With diabetes linked to obesity and a sedentary lifestyle, Brodsky said that Vitamin D may help prevent diabetes in some or most people. But he also said there are indications that for some obese people, Vitamin D becomes “trapped in fat globules” and rendered ineffective.
The study is focused on those at risk for diabetes, but Brodsky said the research may also show that Vitamin D could help people in the early stages of diabetes, potentially slowing the disease’s progression.
“If we find it’s helpful for pre-diabetics, it’s likely Vitamin D will also be helpful for diabetics,” Brodsky said. “Instead of taking a decade before you need to have insulin shots, maybe it would be 20 to 25 years.”
Claudia Leighton of Boothbay, who has Type 2 diabetes, said she hadn’t heard of Vitamin D’s potential to treat diabetes, but coincidentally she had picked up some Vitamin D pills on Friday and was going to start taking them.
“I think it’s worth trying,” said Leighton, 67, who uses an insulin pump. “I have no reason to believe it won’t work or will work.”
Leighton said her mother and grandmother were both diabetic, and Brodsky said genetics do play a role in the disease.
Some who would not otherwise be at risk for diabetes and are at a seemingly normal weight can still contract Type 2 diabetes because their body does a poor job of producing insulin.
Brodsky said people who have skinny legs and not much fat on their buttocks but carry weight on their midsection seem to be more at risk for diabetes.
Regardless of whether Vitamin D is found to be effective, Brodsky said it will not replace diet and exercise, which are proven ways to reduce or prevent diabetes.
“We will not stop pushing people to do what needs to be done lifestyle-wise with diet and exercise, but these pills could also play a role,” said Brodsky, 52, who has studied nutrition for decades. Brodsky is trim, but he said that when he was growing up in Chicago some members of his family struggled with weight problems, and his mother had diabetes.
Having Maine be part of the study could also help determine if exposure to sunlight plays a role in the incidence of diabetes. Vitamin D is also absorbed into the body via sunlight, and Maine, being a northern state with fewer hours of daylight, could test those theories, Brodsky said.
Sandra Barth, a retired diabetes educator at the Lincoln County Health Center’s Miles campus, said she hadn’t heard previously about the national study or the possibility that Vitamin D might help prevent diabetes. The idea is intriguing, she said, but diet and exercise will continue to be most important in treating and preventing diabetes.
“For diabetics, Vitamin D would be one more cog in the wheel. It is definitely not the total answer,” Barth said.
In any event, Rosen said the study will go a long way toward answering questions about Vitamin D and diabetes, because human clinical trials are “the gold standard.”
“This is really exciting and great fun to talk about and do,” Rosen said. “It’s a tremendous study, and it will be at the forefront of medical research on this topic.”
Joe Lawlor can be contacted at 791-6376 or at: