The VITAL Study is Coming!

By , SparkPeople Blogger
The VITamin D and OmegA-3 TriaL (VITAL) research study will officially begin recruitment for participants in January 2010. The purpose of the study is to evaluate whether taking omega 3 fatty acids from fish oil or vitamin D supplements helps reduce the development of cancer, heart disease and stoke in healthy people.

Think you might be interested in participating?

I started my dietetics career as a research dietitian working collaboratively with eight other facilities with VA Cooperative Study Group #275. It was a wonderful opportunity to learn about the research process and to meet some wonderful men who served our country. When our children were little, we participated in numerous Procter & Gamble diaper studies. The local company was always looking for families to use and evaluate new test diapers before they hit the national market. It was a wonderful way to receive free diapers and to participate in making a good product better.

Research requires willing participants. According to, a service of the U.S. National Institutes of Health, participating in clinical trials allows participants to "play a more active role in their own health care and help others by contributing to medical research."

The upcoming VITAL study will be funded by the National Institutes of Health and conducted by Harvard Medical School and the Brigham and Women’s Hospital in Boston, MA. They seek to enroll 20,000 U.S. men and women from all over the country. Eligible participants include women 65 and older and men 60 and older that have not previously suffered a heart attack or stroke or any other cancer besides skin cancer. Selected participants would agree to take 3 pills daily for several years and to limit additional supplementation of vitamin D, calcium and fish oils and to complete study forms and annual questionnaires. All study pills and forms will be provided via the mail and participants are not required to make any clinic visits.

You can learn more about this upcoming study by visiting the study website. There will be further information posted after Labor Day so those interested can request introductory materials and an enrollment questionnaire. I share this information with you now so those of you that are eligible can be thinking about whether you would be interested in participating in research. If you know someone that might fit into this study group that doesn’t read the dailySpark, please pass this along to them as well. This research “could” change future supplementation recommendations for your children and grandchildren that could provide improved health. Wouldn’t that be a wonderful legacy to leave them?

Have you ever participated in a research study? If so, what did you think of the process? If not, would you consider participating in one in the future?

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Several years ago I did a research study on antidepressants. I felt better and did get paid for my time in addition to the free meds. The bad thing was that it was a double-blind study, so they couldn't tell me what they had given me when it was over, as they didn't know themselves. Report
no, i haven't Report
Yes, I have been involved in a few studies for detergent and foods. It is a good way to meet people. Report
I am in the Black WOmen's Health Study to help African-American women get proper medical attention and be more aware of ways they can help physicians help them. I have been in in this study since its inception. I keep my information current and read information on studies they have done. It is very important to help in research studies for the benefit of all and I would do another study if needed. Report
I work at a university who sometimes needs participants for studies. I have helped out with weight loss and appetite studies. Although these are not clinical trials, they do help researchers draw conclusions and make determinations about their research. If the studies are not too invasive or time consuming I enjoy helping out. Report
I'm in the Black Women's Health Study. I learned after the death of a woman I loved when we all thought she was going for a "routine" angioplasty that angioplasty is routine for men and surprisingly dangerous for women, perhaps because when it was originally tested and approved, it was tested on middle aged men. So now I want to be part of studies that consciously include women and people of color. Report
I used to do clin trials when I lived in Raleigh. I was pretty poor back then. There are risks when participating. You can always leave the trial at any point though and it does help society. Report
I'm turning 59 in late December and have been taking a vitamin D supplement for several years now. My eye doctor recommended Omega 3's 4 years ago after I had a corneal abrasion. Both doctors monitor how I'm doing. Report
Since I moved to Raleigh, NC I have volunteered for research a number of times. Last fall I got my husband to go with me as volunteers for flu vacine research. This project will continue for at least one more year.
About one hour ago I opened mail where they wanted us for heart research, but it has to be associated with depression and we don't qualify for that.
One time the medication that was being tried made me very nauseous and I had to drop out of that research. I figured I was getting the real thing and not a placebo. I like to feel I am helping society in some small way. Report
Women have been under-represented in medical research over the years, so women especially should consider volunteering for studies that they qualify for and are interested in! I've been in a couple of medical research studies that were questionnaire based, and one that examined the reliability of some heart rate monitor [many years ago, maybe 2002?]. I had to exercise on a treadmill while they tracked my vital signs. I found out a few months later that a neighbor down the street was the primary investigator on that one [I didn't know her when I signed up for it].
The protocol for being in a test is very specific. I have agreed to participate and have refused after I had Qualified and was told what the study "really" involved. No one can make you do them. And I think of them similar to jury duty. If I can and believe it will have more benefit then any possible bad, I will do it. I am doing one now and am glad I have. I did one 10 years ago and knew I was on the placebo since I was having horrible symptoms and had to get on something that would help me. I, at that time had exhausted the usual meds so I was desperate. When that med was approved my doc prescribe it for me and it worked. I am glad that I gave it a try, since I did end up benefiting from the study in the long run. Report
I have participated in several studies, but none that require taking drugs. The only ones I will participate in are those that use data analysis based on my current health habits, not ones that would force me to adopt bad habits in order to support or refute the premise of the study. I worked to hard to establish healthy habits to abandon them just to be one of thousands of participants in a study. Report
no haven't participated in any. Report
I would love to participate but don't turn 65 until June Report
I have not yet participated in a true clinical study...but would be interested in the future....I don't meet the age requirements of this one though. Report
I have participated in a clinical study before, but it didn't really seem to do me any good. It still bugs me that I don't know if I got the pill or the placebo! lol Report
I hope there will be a companion study funded too, involving similar protocols, tracking food sources rather than supplements. So often the outcomes of supplement-based studies are showing that the there is no outcome, while whole/real food studies are showing a positive effect. It can confuse people who read only the supplement studies into thinking that what they eat is not important. But of course all of that costs and it's good to see this research proceeding! I might join in, though in this case, I'm already focused on whole food sources for these nutrients and probably would not be the best participant as a result. Report
At my last doctor's appointment, my Vit D levels were EXTREMELY low. My doctor put me on a VIT D supplement and strongly suggested I take a multi-vitamin once I completed the Vit D perscription. I had recently changed doctors and this doctor was the FIRST doctor that examined my VIT D levels!! I never new my VIT D levels were low. If you haven't done so, have your doctor checked this for you. I feel so much better now. Report
Turning 65 this fall, makes me want to join such a study. However, I have been taking fish oil for years, and have taken Vitamin D3, 2,000 units over the last 2 years. Originally the D for my bones, but then started to learn of all the other things D was good for. Really was wonderful to learn. But I had already found one BIG good affect of the increased D in my diet, and that was to see my blood pressure NORMALIZE completely over the last 2 years.
I am SO glad for that, because NOTHING was helping my pressure stay WNL and I was really frustrated over that. I am SO glad to hear of a study like this, it is time! Report
A diaper study is pretty low-risk in comparison. My husband was in the CARET study with the Fred Hutchinson Research Center. They wanted to see whether a beta-carotene derivative would reduce cancer cases in high-risk individuals, in this case smokers who did not yet have cancer.

The study was stopped early, because the supplement caused liver damage. So now we don't know which group he was in.

But, there is a good side to this. The CARET study group is huge, and they will keep tracking these individuals for years, making this one of the biggest lung-cancer studies ever. Report
I've always stayed away from such studies, even though I know the items in question must be extensively studied on animals first. I tend not to recommend them to others, either, suggesting they consult with their physician first. There are always risks involved in things like this, even if one is in perfect health. And in the case of those who already ill, as others point out, they could be placed in a placebo group, which, in the case of certain illnesses, could mean untreated progression of the disease or worse. And 3 years of Vitamin D therapy? I thought it was already long known that D in excessive amounts was toxic. Report
I have worked in clinical research for 10 yrs. If anyone has questions on how research is conducted, safety measures in place, etc. I'd be glad to help. Report
I have done research studies many times. I worked at a very large and well known teaching hospital. My only caution is be very sure of the details and side effects of any study. There was a death at our facility, an employee, who had an adverse reaction to the drug. You need to read everything and be totally honest when you answer questions that are presented. Not only for your safety but for the results of the study to be accurate. Would I do one again? I'd have to think very hard about it. Report
"The purpose of the study is to evaluate whether taking omega 3 fatty acids from fish oil or vitamin D supplements helps reduce the development of cancer, heart disease and stoke in healthy people." Why 65 and 60? These conditions do not happen over night and they do happen to people much younger.

I have participated in research studies, but not in a study regarding health issues. A aging loved-one considered it. I was angered that the org. offered them free treatment for their cancer if they would sign a document stating that they understand that as a participant of the research they may not recieve the actual and their cancer could progress while participating in the reasearch.

I would not participate in college or health org. studies as their objective is NOT to protect the participants. Their objective is to prove their point as truth. They DO explain the risks in writing. However, they also tell you verbally anything you want to hear to cause you to participate, then asks you to initital a phrase that says that you did not base your decision on verbal information. That two-sided talk can confuse someone who is trusting. Report
As it happens, I am in the 8th week of a 24 week study of a medical trial now for a drug called GDC-0449. I have a genetic disorder called basal cell nevoid syndrome which makes my body create skin cancers. And there are many other manifestations of the syndrome that affect us. BUT since being on the drug which is a form of gene-altering chemotherapy, my skin cancers (about 50 of them) are fading and some have disaappeared completely! Yes, there are side effects, but compared to the benefits----! Every single pill, tablet, capsule, shot, IV fluid had to go through a medical trial to get approved. I had reached a point in my life where I was tired of being cut on and had decided enough! So when this trial came up, I figured I didn't have anything to lose EXCEPT my skin cancer! So yes, if I weren't already involved in a trial I would be lining up for this one! Report
i have never participated .. and i live in canada. not of age yet but my hubby is . and he'd love to paticipate .. i think it is a great idea. thanks .. Report
I've participated in a clinical trial and the experience was very different from what this project describes (the involvement was only a 12-week efficacy study on a drug already approved for anoteher use). It was a very positive experience as it helped me get a proper diagnosis (the research facililty wanted to make sure I suited the study and there was no drive to "force fit" me into a category as there were many studies I may have been appropriate for).
My mother participated for many years in the Nurse's Health Study while I was growing up. She filled out numerous questionnaires about her lifestyle and health habits at periodic intervals, even occasionally sending in samples of fingernails, hair clippings, blood and water from our home.
My father also has had more recent positive experiences with clinical trials. It's helped him deal with his chronic bronchitic/COPD. The study teams tend to give him more information about how to deal with his condition and up-coming medications that he can discuss with his doctors. There are small stipends that help him defray the costs of travelling to the research offices too. Report
I think we should always go into something like this with our eyes "wide open." But coming from SparkPeople, I would initially trust this research.

That being said, I think WALLOWA before me makes some very good points on research. Report
As a person with chronic conditions who has evaluated participating in research projects before, and have friends who have done so in desperation -- this one sounds pretty benign. However, remember, you might wind up in the control group, which may or may not help you. There are pluses and minuses of participation in these things so CHOOSE CAREFULLY. The point of research studies is to evaluate something, and YOU are the guinea pig. So... think carefully. That said, there's usually pretty good follow up when you are in a study, and there are some incentives that make it worth considering.

On the other hand, these are UNtested strategies, pills, what have you -- that's why they are testing them on people. Sometimes there are unwelcome consequences.

As I say, this looks pretty benign... however I'm probably not going to risk being in the control group, because I already do find some benefit from D/Calc supplementation (experientially) and don't care to take the chance of being in the control group. I guess it's a control issue!!!!

If you think carefully about it and want to -- it should be okay or even good -- but remember, they are not in it for you, they are in it for them. In addition to personal medical condidtions, I worked on an EIS associated with development of taxol (long story) and it's a pretty ruthless, single minded process. (And I think the studies are all worth doing, mind you, but keep in mind they are in it for something other than your well being.)

Eyesies open? Make your choice. You don't need to be intimidated by this. Just look out for you! Report
I take both of these supplements at my doctor's suggestion. While I don't qualify for the study, I will be very interested in the results. Report
I belong to the National Weight Control Registry. Its not a clinical trial, but I believe it is considered a research project. Depending on what it was, I would be interested in doing a clinical trial. I would have to weigh any personal side effects, but if there's something simple I can do that may in the future help many others, why not? Report
I do not qualify at this time. But will encourage my husband to participate. I would be willing to participate in any research that I am eligible for. Report
I've never participated in a study before but I would be interested in doing one. I'm always looking on the Health news to see if they have any I'm eligible for. I've never heard of being too young but I am. Besides I've had Cancer before. Report
My doctor has recently put me on 4000 IU of Vit. D. I live in northeast Ohio where we are short on Vit. D. The reason was to help reduce pain and inflamation. I thought he was crazy but it was worth a try. Guess what - it's working! I have greatly reduce my usage of ibuprophen. I hope it works for the things stated in this trial. Good Luck to all who join the trials. I will be excited to hear the results. Report
I have never done it but wouldn't mind if I have a chance. Seems interesting. Report
I have participated in a clinical trial for a herpes drug, and a ostopenia drug. Both times it was a good experience. You get free tests for your own records, and the clinic folks are so nice and helpeful-they make you feel important.Since I take both of these supplements - post menopausal- I'd do this one ina heartbeat.
Here's to more - heartbeats(and clinical trials)
Candy Report
Surveys don't usually want my opinion cuz I'm too old. Finally, I'm too young again! I think I'll check and see how to find other's I might qualify for. Depending, I'd be willing to participate in a health study figuring even if it didn't help me, it might help my grand...great grand children. Report
I have cancer, so I'm pretty sure I wouldn't be eligible for the study.
My oncologist has me, as he does all of his breast cancer patients, on 1000 IU of Vitamin D3 twice per day. Report
I've participated in a couple of clinical trials and several outreach studies over the years. I joke that I'm selling my body to research on piece at a time! @8~) I've also worked on the other side of the desk. I've enjoyed all my time participating in the research process and it feels good to know I'm doing something that could help others.

I'm still too young for this study but will be interested to see the results when they come in. Report
I just completed a clinical trial (at least my 3rd) on HBP medications effects on the gastrointestial system today. I'd love to participate in this study but cannot for a couple of reasons. I encourage anyone who is interested in furthering our understanding of health and the body to participate if eligible. Report
I think that this is very good. It would be great to hear more about but as stated I too am not eligible at this time. However it is something that I may mention to my mother. Report
It is interesting that I have to be older then 65. So I cannot participate just becuase I am too young. Report
As a budding researcher myself, I think it's good karma to participate in other people's projects. I am constantly filling out surveys and offering myself up as a participant in studies for my peers at school. One thing I've learned is that Institutional Review Boards don't let things pass that could do more harm than good unless the researchers are very upfront about the possible risks and have a darn good reason for doing the study. It makes me feel a little more comfortable with being a participant in these types of things. This seems like a great opportunity to help out the medical community. I would do it if I qualified! Report
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