According to research, there are evidence to suggest the importance of vitamin D and marine omega-3 fatty acids in reducing the risk of cancer and cardiovascular diseases. However, scientists are reluctant to accept these findings in order to declare vitamin D and Omega 3 in adequate dosing, and in adequate frequency, as having the ability to reduce such risks. Thus, the lack of clinical evidence by means of large-scale primary clinical trials to back up some of the earlier research findings gave rise to the design of one of the largest studies undertaken to assess the clinical effectiveness of vitamin D and omega 3. The study is named as the VITAL study, which stands for “Vitamin D and Omega 3 Trial” and is conducted by the Harvard affiliated Brigham Women’s Hospital in Massachusetts, Boston.
What is the aim of VITAL study?
According to the clinicaltrials.gov, the purpose of the VITAL study is “investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or fish oil (1 gram of omega-3 fatty acids) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses.” It further states that in order to fulfill the above purpose, the research shall tackle the conditions of cardiovascular disease and cancer through the use of vitamin D3, omega-3 fatty acids (fish oil), vitamin D3 placebo and fish oil placebo on a 20,000 strong participant cohort which includes both men and women.
What is its overall research design?
As mentioned earlier, the research hopes to recruit almost 20,000 participants above the age of 50 years for men and 55 years for women. The study is an interventional study, which makes use of randomized allocation of the participants for four types of treatment, which also includes placebo treatment. During the study, the subject or the participant, the investigator and the outcome assessor would be blind to the treatment given for a particular participant and therefore the trial can be categorized as a ‘double blind’ clinical trial. The mean treatment period would be 5 years and throughout the study, the participants have to fill out a short questionnaire annually. These questionnaires will ask from the participants questions related to their diet, exercise habits, smoking and other lifestyle habits, medications and dietary supplements, family history of illness and new medical diagnosis. The research also expects to collect around 16000 blood samples and around 6000 follow-up samples during the study period.
What are the ancillary researches carried out along with the VITAL study?
While the VITAL study continues, researchers will also look into the various influences the agents might be having on diabetes, glucose intolerance, hypertension, glaucoma, cognitive decline, depression, osteoporosis, asthma, respiratory diseases, thyroid diseases…etc in order to recognize such associations.
What are the criteria to select the study participants?
According to the clinicaltrials.gov, the selection criteria of the participants would contain additional requirements apart from the participants’ age and the necessity to have a clean medical record in the past. These additional criteria include, having no allergy for fish oil or soy and consuming no more than 800 IU of vitamin D from all supplemental sources combined. However, if taking in excess, the participant should agree to forego or decrease such treatment during the study period. Similarly, they should consume no more than 1200 mg/d of calcium from all supplemental sources combined or if taking in excess, should forego or decrease such treatment during the study period. At the same time, those who are taking fish oil supplements should also consent to forego or decrease such treatment.
When did the VITAL study start and when is it expected to be complete?
The VITAL study began in July 2010 and is expected to be complete by June 2016.
Thus, following this 5 year large scale primary clinical trial, it would be possible to ascertain the effect of vitamin D and omega 3 in relation to cancer prevention and cardiovascular risk reduction.