I am not going to post a link, yet, for this study showing no evidence for large doses of vitamin D for severe asthma in children with low vitamin D. I read it with frustration, as it showed no benefits even with 4000 IU/day in this RCT. Frustrated since I knew of previous RCTs which had impressive, even huge, result giving D to children and dropping flu a lot and the asthma attacks by over 80%! So how could this RCT have found " In this randomized clinical trial that included 192 children, vitamin D3 supplementation, compared with placebo, did not significantly improve the time to a severe asthma exacerbation (adjusted hazard ratio, 1.13).
Meaning: The findings from this trial do not support the use of vitamin D3 supplementation to improve the time to a severe asthma exacerbation in children with asthma and low serum vitamin D levels."?............... WTH is going on? Either this study is screwed up or the previous, actually larger, studies are screwed up. (the only good news out of this study is that, despite a whopping 4000 IU/day FOR CHILDREN, "There were no cases of hypercalcemia or vitamin D toxicity in either treatment group.".
So, I started digging. And like in the previous study I reported on a few posts back in this thread when I said: "I predict that this study will fail to show any benefit. I very much hope I am wrong. It seems to me that these guys just can't learn, or they don't want to. As in a previous thread of mine asking if studies are designed to fail. ". Once again, another, IMO, crappy study. Why do they bother? Unless they have a bias and the goal is to show no benefit for this cheap, non prescript
ion supplement? If that was there goal, then the way the study was done makes sense. If they just wanted to truly find out if vitamin D was helpful in avoiding asthma attacks, this study could be greatly improved.
First, I find this: "During the trial, vitamin D levels were measured during in-person study visits at 0 (randomization), 16, 32, and 48 weeks.
Study medications were discontinued in participants with a vitamin D level less than 10 ng/mL (n = 2), who were referred to a pediatric endocrinologist for evaluation and followed up in the group to which they were randomized. Participants whose vitamin D level was between 10 and 13 ng/mL (n = 10) received additional dietary counseling along with a randomly selected participant (to prevent unblinding);
if their vitamin D level was less than 14 ng/mL at a subsequent visit (n = 2), study medications were discontinued and the participant was referred to a pediatric endocrinologist and followed up in the group to which they were randomized.".
Now, for me that is a little confusing. But is this saying(I think it is) that they removed the children with the lowest vitamin D levels, the ones likely to have the greatest need for supplementation? Why on earth would they do that? Why not just continue giving these children the 4000 IU/day of D3 and see if it helped them or not? So it seems to me they removed the very patients - those with <14ng/ml D - who were in greatest need of their supplements, and only compared to those who who did not need supplementation nearly as much, those between 14 and 30 ng/ml "eligible participants were high-risk children with asthma, aged 6 to 16 years, with serum vitamin D levels less than 30 ng/mL but.......... greater than or equal to 14 ng/mL ". That to me sounds sort of insane if you are trying to find out if very low D levels contribute to asthma flare ups and if getting blood levels fromvery low to at leat 30 ng/ml will help any. Is it just me, or is that a crazy way to do things?
Next, I found this and, along with the next item, tells the real story(and I have run into the same crap in other studies that showed no benefit):
They did not make sure that the placebo group did not supplement on their own, and that group did indeed supplement on their own. How did I figure this out? Simple: with very rare exceptions, no one has a greater than 30 ng/ml D level unless they supplement. Most are well below 30 and even 20. Many of you here(I know of 1 exception) could personally testify to this. Look at this revealing line from the study:
"Compared with participants in the placebo group, those in the vitamin D3 group were significantly more likely to
achieve a vitamin D level of 30 ng/mL or higher (94.4% in the vitamin D3 group vs
40.7% in the placebo group at 16 weeks"..... !
Do you see that? Even though "The mean (SD) baseline serum vitamin D level was 22.5 (4.6) ng/mL in the vitamin D3 group and 22.8 (4.6) ng/mL in the placebo group.", even though base line D level were virtually identical in both groups, and both groups pretty typical of mean levels one might find if first removing every one less than 14 ng/ml- IOW, the low 20s,
some how 41% of those in the placebo group managed to increase their levels to 30 ng/ml or higher by the first recheck at 16 weeks. Now would any one like to tell me how they did that without supplementing? Well, they didn't. Some or many in the placebo group obviously supplemented with Vitamin D,
diluting the differences between the two groups. Next is the final tell: "Conflict of Interest Disclosures: Dr Bacharier reported receiving grants from the National Heart, Lung, and Blood Institute (NHLBI) during the conduct of the study and personal fees from AstraZeneca, GlaxoSmithKline, Sanofi, Regeneron, Novartis, Genentech, Boeringher Ingelheim, Vectura, DBV Technologies, Circassia, Merck, Teva.........................Dr Phipatanakul reported serving as a consultant for GlaxoSmithKline, Genentech, Novartis, Regeneron, Sanofi, and Teva; receiving clinical trial support or medications from Genentech, Novartis, Regeneron, Sanofi, Circassia, Monaghen, Thermo Fisher, Alk Abello, Lincoln Diagnostics, GlaxoSmithKline, Kaleo, and Merck; and funding to the institution by Genentech, Regeneron, Novartis, and the National Institutes of Health (NIH)—all for projects unrelated to the current work. Dr Guilbert reported receiving personal fees from GlaxoSmithKline, TEVA, Novartis,.....................grants and personal fees from Sanofi/Regeneron; grants from AstraZeneca and Novartis...........Dr Covar reported receiving grants from GlaxoSmithKline during the conduct of the study. Dr Gern reported receiving personal fees from AstraZeneca ............".
Good grief! This study was essentially paid for by drug companies and performed by researchers on the pay roll of drug companies. So do you suppose it is reasonably possible that one or more of these guys might have a bias and want to arrange things to show no results in favor of a cheap, non patented substance that might decrease demand for some of their mega buck drugs? It is certainly possible, and IMO would explain why they would first want to remove those with the lowest blood D from the study, as well as fail to make sure that no one in the so called placebo group was not taking the product being investigated, i.e. supplemental vitamin D. This might also explain why the results of this study so directly contradict the results of several other RCTs, which I have linked to here in the past.
OK, I said I wasn't going to provide a link to this study, but after writing all of the above, I guess I really should. But to me, the lesson of all of this is: we have to take all studies with a large grain of salt, and they all must be searched for bias. And there are certainly plenty of studies with a bias to show a pre-determined result. But, there is a rather huge financial incentive to show that something like vitamin D is useless compared to expensive prescript
ion drugs. I mean, if these guys were paid by a vitamin D manufacturer, and a bias existed to show a great benefit, who is really going to make big bucks off of that? Sure, it might increase the over all demand for D a bit, but considering how any companies can make and sell D, no doctor or prescript
ion needed, any increase in demand would just be divided among all of those companies, so why bother trying to rig a study? I'm not saying it doesn't happen, I'm just saying there is a much bigger financial incentive to show it is worthless.
https://pubmed.ncbi.nlm.nih.gov/32840597/This link may not work for everyone, but I will try, it is the full text:
https://jamanetwork.com/journals/jama/fullarticle/2769724?guestaccesskey=0ce0a70b-a1f5-4fe8-b8ff-70576e18497f&utm_content=weekly_highlights&utm_term=083020&utm_source=silverchair&utm_campaign=jama_network&cmp=1&utm_medium=email#note-joi200079-1Post Edited (BillyBob@388) : 8/31/2020 2:04:15 PM (GMT-6)