I TA
Vital Signs
V
L
Spring 2011
No. 1
News and information for participants in the VITamin D and OmegA-3 TriaL (VITAL)
From the VITAL Study Directors New national guidelines for
Dear VITAL participant,
vitamin D intake highlight
As the VITamin D and OmegA-3 the need for the VITAL study
TriaL (VITAL) gets underway, we
Y
wish to thank each of you for your ou may have heard about a benefits and risks of doses of vitamin
commitment to this important new report from the respected D above the currently recommended
research study. Your participation, Institute of Medicine (IOM), amount is to carry out a large randomized
along with that of 20,000 other
released in late 2010, that made clinical trial such as VITAL—that is,
men and women
recommendations about the amount of randomly assign one group of people to
throughout the
vitamin D that most Americans should take a vitamin D supplement and assign
country, will allow
us to determine
consume. The IOM recommended 600 another similar group of people to take a
whether a daily international units (IU) per day for people placebo and then track health outcomes in
dietary supplement aged 1 to 70 and 800 IU per day for those both groups for several years. Indeed, large
of vitamin D3 (2000 aged 71 and older (an increase from the trials of other widely used supplements
JoAnn Manson, MD
IU) or omega-3 fatty 400-600 IU/day previously recommended have sometimes found benefits, but in
acids (Omacor® fish for adults at midlife and older). other cases—such as with high doses of
oil, 1 gram) reduces the risk for To develop its recommendation, beta carotene, vitamin E, selenium, and
developing cancer, heart disease, the IOM reviewed nearly 1000 scientific even calcium—have debunked some
and stroke among people without studies of vitamin D in relation to not health claims for these supplements and
these conditions at the only bone health but also many other uncovered health risks that may not have
trial’s start. During the
health outcomes. It concluded that there otherwise been detected.
course of the study, we
is clear evidence that vitamin D has Given the current lack of evidence for
will send you periodic
bone benefits but that current research is non-bone benefits of vitamin D, the IOM
newsletters to keep
you informed about the
inconclusive as to whether higher vitamin based its vitamin D recommendation
study’s progress, as well D intake can cut the risk for cancer, on the amount required for bone health
as health topics that we heart disease, stroke, or other chronic only. The new guidelines call for a daily
Julie Buring, ScD
hope will be of interest. diseases. We simply don’t know whether intake—or “recommended dietary
We will also answer frequently vitamin D supplements are beneficial in allowance” (RDA)—that will meet the
asked questions from participants preventing diseases beyond osteoporosis vitamin D needs of at least 97.5 percent
in our newsletters and on our study or other bone disorders—nor do we know of U.S. and Canadian residents. As noted
website, www.vitalstudy.org. (For an the amount of vitamin D that might be earlier, these RDAs for adults are 600 to
update on when we will be mailing necessary to do so. 800 IU per day. Although the sun activates
the study pills, see the Q&A section Because of this uncertainty, the IOM vitamin D production in our skin, the
on page 4.)
called for more research to determine (a) IOM assumed little or no sun exposure
Thank you again, and welcome to whether higher doses of vitamin D can because of differences in people’s ability
the VITAL study! lower the risk for cancer, heart disease, to produce vitamin D—resulting from
stroke, and other chronic illnesses and (b) differences in skin color, as well as season
JoAnn Manson, MD
whether such doses pose any health risks.
Julie Buring, ScD — continued on page 2
The only sure way to identify the health
The VITAL
research
team
— continued from page 1
The IOM also carefully reviewed Together with intake from food (which
of the year, location of residence, and use available safety data on high-dose averages 200 to 300 IU/day*), most
of sunscreen—and concerns about skin vitamin D supplements before raising the participants will be able to consume at least
cancer. This means that the guidelines are acceptable upper limit of daily intake to 1000 IU of vitamin D daily, which is more
adequate for everyone, including those 4000 IU for adults, from the 2000 IU than the new RDA. Thus, no participant
living in the northern United States during set previously. Extremely high intakes of should become vitamin D deficient due
the winter when the sun’s rays are weak. vitamin D can lead to too much calcium to participation in the trial, even if he or
The IOM’s report challenges the in the blood and damage the kidney and she is in the placebo group. Moreover, no
notion that many Americans are vitamin heart, but whether moderately high doses participant who is assigned to take vitamin
D deficient and cautions against the need of vitamin D have side effects is not yet D will get too much unless he or she also
for widespread blood tests for vitamin D. clear. takes a non-study vitamin D supplement
Many laboratories consider a vitamin D Given the new IOM report (by the containing more than the 800 IU per
blood level of 30 or 40 nanograms per way, one of the study directors, Dr. JoAnn day allowed. In other words, participants
milliliter (ng/ml) to be best, but little Manson, served on the IOM panel), in the vitamin D group who follow the
research supports this claim. The IOM’s we want to assure you that VITAL has study’s requirements will be consuming
recommended intakes correspond to been designed to ensure the safety of its at most about 3000 IU of vitamin D per
a vitamin D blood level of 20 ng/ml participants, whether they are assigned to day, which is well within the IOM’s safety
—again, sufficient to maintain strong take placebo or pills containing vitamin range.
bones for at least 97.5 percent of the U.S. D at a dose of 2000 IU per day. VITAL VITAL is designed to answer the
and Canadian population. Most people allows participants to take up to 800 scientific questions regarding vitamin
meeting the intake guidelines do not need IU of vitamin D per day in nonstudy D that are considered important by the
a vitamin D blood test. supplements should they choose to do so. IOM: do vitamin D doses above the
new RDA prevent cancer, heart disease,
stroke, and other non-bone diseases? We
Ancillary studies are grateful that you have chosen to enroll
Although the main goal of VITAL is to test whether vitamin D or omega-3 in this landmark trial—and to take your
fatty acids can prevent cancer, heart disease, and stroke, we will also assess study pills faithfully—to help us obtain
whether these supplements confer other health benefits, such as lowering
much needed information about the
the risk for:
health effects of vitamin D and omega-3
• diabetes fatty acids (fish oil). Although the
• high blood pressure Recruit a pal
We will be recruiting
omega-3s haven’t made headlines as often
• memory loss or cognitive decline
participants for VITAL as vitamin D lately, scientific research
• autoimmune conditions such as
throughout 2011. Please spread regarding their health benefits remains
thyroid disease, rheumatoid arthritis,
the word to friends and family promising though inconclusive. VITAL is
and lupus
(men aged 60 or older or the first and only large trial to study the
• Other conditions (including infections,
women aged 65 or older with
asthma, depression, fractures, chronic health effects of omega-3 supplements in
no history of cancer, heart
knee pain symptoms, and physical attack, or stroke) about this
people who are generally healthy.
disability and falls). important research—you can
*Natural food sources of vitamin D include fatty fish
You will hear more about these studies refer those who are interested (such as salmon, sardines, and mackerel) and eggs.
later. In addition, a small subgroup of to our website, www.vitalstudy. Vitamin D is also added to milk and some other dairy
org, or ask them to call us toll- products, cereals, and orange juice (check product
participants will be invited to come for labels).
free at 1-800-388-3963.
optional clinic visits to have more detailed
studies.
Numbers to know for your Educational Corner
heart’s health
M
any factors are known to Association adopted the slogan “Know (the top number of a blood pressure
increase the risk for coronary your numbers” to boost the public’s reading, or your pressure when your heart
heart disease. The more risk awareness of heart health. Let’s review 11 contracts) and diastolic pressure
factors a person has, the greater the numbers that are worth knowing. (the bottom number, or your pressure
likelihood that he or she will develop The fats in your blood are collectively when your heart relaxes). The higher each
heart disease and suffer a heart attack. known as lipids, the most important of reading is, the greater your chance of
Some risk factors are beyond your control, which are LDL (bad) cholesterol experiencing a heart attack or stroke.
including increasing age and a family and HDL (good) cholesterol. The Excess weight—especially at the
history of heart disease. However, most lower your LDL and the higher your waist—adversely affects heart health.
risk factors, including an unfavorable HDL, the lower your odds of having Body mass index (BMI) indicates
cholesterol profile, high blood pressure, a heart attack. Total cholesterol weight in relation to height. To calculate
and high blood sugar, can be modified is a useful general measure. High your BMI, multiply your weight in
by making relatively simple lifestyle triglycerides also increase risk, pounds by 703, divide the resulting
changes—quitting smoking, increasing especially in combination with excess number by your height in inches,
physical activity, losing excess weight, and weight, high blood sugar, and low HDL and then divide again by your height
improving your diet—and, if necessary, cholesterol. in inches. Individuals with a BMI of
taking certain medicines. Your blood pressure has two 18.5 to 24.9 are considered to be at
Some years ago, the American Heart components: systolic pressure — continued on page 4
Do you know your numbers?
Indicator Ideal When to worrya How often should Write your
It be measured?b number here
Lipids Every 5 years
Total cholesterol Under 200 mg/dL 240 mg/dL or higher
HDL cholesterol Over 50 mg/dL 40 mg/dL or lower
LDL cholesterol Under 100 mg/dLc 160 mg/dL or higherd
Triglycerides Under 150 mg/dL 200 mg/dL or higher
Blood pressure Every year
Systolic Under 120 mm Hg 140 mm Hg or highere
Diastolic Under 80 mm Hg 90 mm Hg or higherf
Body measurements At every physical exam
Body mass index Under 25 kg/m2 30 kg/m2 or higher
Waist circumference
Men Under 35 inches 40 inches or higher
Women Under 30 inches 35 inches or higher
Fasting blood sugarg Under 100 mg/dL Over 125 mg/dL Every 3 years
Hemoglobin A1ch Under 7%h Over 8%h Every 3 to 6 monthsh
C-reactive protein (CRP)i Under 1 mg/L 3 mg/L or higher Not determined
a. When to take action beyond lifestyle changes. These numbers may be different for people with heart disease, stroke, diabetes, or
other medical issues.
b. More often for people with abnormal values or at increased risk for heart disease.
c. For people who have an LDL cholesterol level below 100 mg/dL but are at high risk for heart disease because of other risk factors, a
goal of below 70 mg/dL is recommended.
d. This depends on how many other risk factors are present. For people with many risk factors, an LDL over 100 or 130 suggests the
need for treatment with cholesterol-lowering medications; for others, an LDL of 160 or more, or 190 or more, does so.
e. 130 mm Hg or higher for people with heart disease, diabetes, or kidney disease.
f. 80 mm Hg or higher for people with heart disease, diabetes, or kidney disease.
g. People with blood sugar levels of 100 to 125 mg/dL have prediabetes, and those with blood sugar levels of 126 mg/dL or higher have
full-blown diabetes.
h. For people with diabetes. Goal may vary depending on other risk factors.
i. CRP levels may vary by race/ethnicity. Some guidelines recommend CRP screening (using a high-sensitivity or cardio CRP test) for
people at moderate risk for heart disease by virtue of other risk factors.
Vital
Q&a — continued from page 3 have this syndrome, which is associated
Q. When will I receive my study a healthy weight, while those with a with an increased risk for diabetes, heart
pills? BMI of 25 to 29.9 are overweight, disease, and stroke.
A. As you know, we have had and those with a BMI of 30 or more
a delay in the shipping of our are obese. To determine your waist Estimating your heart disease
study pills due to a change in the circumference, hold a tape measure risk
packaging. Our new packaging at the level of your navel and circle your There are tools that use your numbers to
provides excellent protection of
torso with it. Measure below, not at, the estimate your likelihood of having a first
the softgel capsules against heat
narrowest part of your abdomen. heart attack or being diagnosed with heart
and humidity. Our current plan is to
Diabetes, or high blood sugar, is disease in the next 10 years. One widely
begin mailing study pills (in calendar
packs) by early summer. We will
harmful to the heart. Fasting blood used tool is the Framingham risk score.
begin on a rolling basis, but nearly sugar provides a snapshot of your Go to http://hin.nhlbi.nih.gov/atpiii/
everyone who has already returned blood sugar at one point in time, while calculator.asp, or ask your healthcare
questionnaires will receive pills this hemoglobin A1c gives a time-lapse provider to calculate your score. Two
summer. The good news is that you look over several weeks. Although doctors web-based tools—www.reynoldsriskscore.
can rest assured that your study pills typically order the org and www.
have met the highest standards of latter test only for all of us can yourdiseaserisk.harvard.
quality control! patients with diagnosed edu—developed by
diabetes, some are now benefit from researchers at Harvard
Q. Will my health information be also recommending Medical School and
kept confidential?
it for individuals at
adopting healthy Harvard School
A. Yes! We are committed to
protecting your privacy. Information
higher-than-usual risk lifestyle choices... of Public Health,
for diabetes and heart respectively, give
from completed questionnaires and
disease. alternate estimates of
medical records is identified in our
Other substances in the blood, your heart disease risk. The Harvard tools
computer files by study number only,
including C-reactive protein (CRP), incorporate a wider array of potential risk
and only a few staff members have
homocysteine, lipoprotein(a), and factors than does the Framingham tool.
access to the file that links study
numbers with participants’ names. fibrinogen, have recently been linked to an The latter Harvard website also offers
Your information will be used only for increased risk for heart disease. Of these, personalized tips for prevention, as well as
VITAL, and no personal information CRP has received the most publicity. An tools for estimating your risk for stroke,
will identify participants in published elevated CRP level indicates low-grade diabetes, certain cancers, and osteoporosis.
research findings. Your trust is inflammation, a process implicated in Being aware of your heart disease
essential to the success of the study, heart disease. However, it is unclear exactly risk may motivate you to make healthy
and we would never do anything to what level of CRP increases your risk and lifestyle changes and will help your doctor
risk losing your faith in us. whether controlling CRP will help lower determine whether to prescribe certain
that risk. medicines to lower your risk. Drugs that
Having more than one risk factor lower blood pressure or favorably affect
I TA
for heart disease is especially worrisome, cholesterol levels can prevent heart attacks
V
L
because risk factors tend to “gang up” to and increase survival in people at above-
worsen each other’s effects. One potent average cardiovascular risk. All of us can
VITamin D and OmegA-3 TriaL
cluster—an increased waist circumference, benefit from adopting healthy lifestyle
(VITAL Study)
900 Commonwealth Avenue East high triglycerides, low HDL cholesterol, choices and, when warranted, taking
Boston, Massachusetts 02215 high blood pressure, and high blood medications. Indeed, the greater your
Telephone: 1-800-388-3963 sugar—is known as the metabolic cardiovascular risk is, the greater the payoff
E-mail: vitalstudy@rics.bwh.harvard.edu syndrome. About 1 in 4 U.S. adults from prevention efforts is likely to be.
Website: www.vitalstudy.org