One pharmacist’s description of an ideal vitamin D trial
The following was a comment by A Ron Carmichael on Vitamin D Council
Please visit Ron’s extensive Vitamin D website
Bulletpoints/highlights by VitaminDWiki
10,000 participants for 6 months
Appears that participants should have 1 of the top 10 diseases known to be treated by vitamin D
Participants to buy their own vitamin D + cofactors
Start in Nov in diverse locations around the US – from Florida to Alaska
Goal of 50 ng/ml, decrease dosage when > 70 ng
Monthly vitamin D blood tests
Start first month with 1000 IU/ 100 lbs for every 10ng lower than 50
- Example: 200 lb person starting at 20 ng: 6000 IU = 1000 * (200 / 100) * (50 – 20)/10
- Next month: if have not gotten 1 /2 the way to the goal of 50 ng, double the dose
- double the dosage – example above: if < 35 ng double dosage to 12,000 IU
My ideal study, Brant? I’ve never created a study and as a college pharmacy student only participated in one :) Off the cuff…..
I would rely on the relatively new methods of performing comprehensive retrospective analysis with computer programs, algorithms, to take a large quantity of subjects gathering instead prospective data, with less lofty conclusion goals. Quantity defines its own quality to a degree.
You know of huge long term studies of nurses on baby aspirin, for example, that spanned many years. Meaningful conclusions came from these kinds of studies. I think we need such a type for vitamin D3.
Activate the study on November 1 in the northern hemisphere and target 8 states that have representative proportions of ethnic groups similar to the overall average across the US with regard to the four or five largest ethnic groups. Not saying other groups do not desperately need the same kind of evaluation, but I think that would be phase two, once the problems and shortcomings of this study are identified so that a more precise/accurate protocol can be used. The states are each further north than the previous – say, Florida, Nebraska, Oregon, and Alaska – perhaps increase with some eastern seaboard states for “balance” – N Carolina, Illinois, New York, Maine.
By volunteers willing to purchase their “special” vitamin D3 (say the BioTech D3PLUS which has more than just D3) on their own at a set, special lower-than-retail price from a particular single source, accept 10,000 adults employed full-time (for chronicity stability – they have routines of life habits that stabilize the substrate) between 18 and 60, who remain under the care of their primary care physicians – both of whom agree to a user-friendly protocol guaranteeing anonymity of the patient but sharing of fundamental assets of the patient’s file. It is critical that the first stage establishes just how much D3 is needed for each subject to reach at least 50 ng/ml . The dr. will have to assess tan lines to estimate (against a contrast card) the degree of sun exposure for the skin type (presuming that we don’t have many nudists in the study who don’t have tan lines). The card also provides a way to rate the untanned skin tone type, a datapoint under consideration. The patient gets a 25(OH)D test in the first week of November, and each month thereafter.
For December, for every 10 ng/ml the subject is below 50 ng/ml, the protocol the dr. follows requires an increase in daily D3 oral dosage of 1,000iu per hundred pounds of weight, rounding up in all cases where a fraction of 1000 occurs.
In January, if the blood level still fails, the subject is directed to increase based on a proportional formula based on the response seen to the first adjustment. Simply, if 1k/100 lbs//day got them 1/2 way up from the level on day 0 and day 32, the physician directs the subject to go to 2k/100 lbs//day. Overshooting 50 ng/ml is recorded but not considered problematic unless it exceeds 70 ng/ml.
During the study, the physician uses a web-based form to log specific disease states, and the physician’s subjective assessment of severity of condition of that DZ. The form displays what the dr. chose (say on a scale of 1 to 10 where appropriate, or else the insulin dose required and the A1C value, or the lipid levels, what ever lab values the physician uses to monitor that patient anyway, are gathered into the database. In most cases this entry will probably be performed by staff in the dr’s office, so I am concerned about compliance in data entry. It may be that the protocol outlines that only the two / three “worst” conditions are tracked.
In addition to the 2 or 3 chronic conditions being treated/monitored, the advent of a new condition including especially acute types such as “flu”, respiratory infections, ear infections, fevers of undetermined origin, bowel problems, etc. should be documented.
The college pharmacy students I would enlist to run the database coding and compilation for the information would proactively call the drs to help them keep up to date.
Perhaps a carrot for the drs would be a guarantee to share information at each month – simply a statistic of what is needed to get patients to 50 ng/ml for their particular state (and for the other states as well). This is a critically important feedback tool to help all practitioners get their subjects to 50 ng/ml as quickly as possible.
And also as data builds to the point where trending can be performed, those trends, regardless of what they are, are labeled and shared as “non-statistical” preliminaries . I would expect the first such “bulletin” be sent out at 5 or 6 months.
As for the placebo section – I think the placebo aspect would simply be that the physician ask patients 1) do they take vitamin D3, do you take a multivitamin? if they answer no to both, and say yes to would they like to provide their blood levels of 25(OH)D for “the next 6 months”, and follow them in a similar way with reporting, and ask the patient to maintain their habits (no D3, no multivits). Dr. performs same short form online evaluation and information is pipelined the same way.
I have absolutely no idea of how this would be paid for. Even the volunteer nature, involving pharmacy students and an open appeal to patients, who will be allowed to purchase low-cost D3Plus from one company who then receives the publicity of supporting science and the advancement of health. I think the college of pharmacy at my alma mater, who work in concert with a large health science center where I also performed rotations in clinical and drug information capacities, could be one “center” as part of a “multi-center” approach to this – each state to have one college of phr. participating on the back end drudge work.
GOAL: finally. I think the best that can be hoped for is a better awareness of just how much D3Plus does what for the average American, whether getting natural levels of 25(OH)D has any effect on weight, existing disease states, incidence of acute DZ. (and more that better minds will be able to figure than I can).
It occurs to me that it would be better to identify and limit consideration to say, TEN diseases that have already been shown to be responsive to D3 , in order to add data to the conversation already in progress. Any of this stick to the wall or is it absurdly naive to think something so lax could pass review in today’s climate?