17 of the reasons that Vitamin D trials fail

.1) Trials rarely allow modifying the dose size - so as to compensate for
   age (weight of child)
   health problems - especially those that consume Vitamin D
   pre-existing deficiency
   gut problems
   poor Vitamin D genes ( many are not noticed by the Vitamin D test)
   no gallbladder
   use of drugs such as statins
   smoking,

2) Trials often do not last long enough
  About 1/3 of the trials that I read would have had a benefit if they had only lasted longer
  but to minimize trial costs, trials are kept short

3) Trials essentially must be monotherapy -no cofactors such as Magnesium permitted
  Meta-analyses rarely consider trials with co-factors, so if a researcher wants his data to be used he does not use cofactors   1

4) Many trials use too small a dose to possibly make a difference
  Have seen many trials just using 1,000 IU
  One trial used just 200 IU - and did not find a difference!!
  Imagine a trial using 1/20 a dose of Aspirin - it would be very unlikely to find any benefit

5) RCTs typically require a placebo group, but many researchers now find it unethical to not give vitamin D to all participants
  so their trial is not an RCT - note that an increasing Percentage of the Vitamin D proofs are not RCT

6) Some RCTs are now terminated because
   Researchers found too much pain/suffering in those getting the placebo (unethical to give placebo)
     Examples: 1, 2, 3,
   Too many participants getting the placebo dropped out as they noticed the other group feeling much better and having fewer health problems

7) Some countries (about 30%) consider a mere 20 nanograms to be sufficient for all health problems
   When they compare those with < 20 nanograms to those with > 20 nanograms they do not see any benefit
   Occasionally, they include charts of the data, in which the benefits of vitamin D can be seen at 30 or 40 nanograms

8) RCTs ignore gene differences that reduce Vitamin D getting to the cells
   There is at least a 3 times increased risk for 12 diseases for people having just a Vitamin D Receptor problem
   Note: There are 5 additional important Vitamin D genes

9) RCTs sometimes use long times between doses
   > 3-week dosing interval provides less benefit
   > 6-month dosing intervals can result in problems (negative benefits)

10) RCT researchers are occasionally rewarded for NOT finding a benefit
   Example; Professor who concluded that vitamin D (800 IU) does not help bones got 324,000 dollar prize- Nov 2015

11) RCTs rarely use loading doses to restore vitamin D levels in a week or so
   Without loading doses many people will fail to show a benefit/get repleted within the typical short RCT length

12) Some RCTs mistakenly continue to use Vitamin D2
   D2 is significantly less effective the D3 - especially for non-daily doses
   Sometimes D2 actually reduces the level of D3
   Over a decade ago Vets decided that Vitamin D2 should not be used on ANY mammal
     guess we have to remind doctors that humans are mammals too
13) Some RCT's give Vitamin D when many participants already have enough

14) All participants were allowed to take some vitamin D
   Many elderly now take 800 IU of vitamin D - which is 40% of 2,000 IU

15) RCT was given in an area with low Magnesium in water
  Too little Magnesium in groundwater
  Too much Magnesium and Calcium in groundwater - so water is deharded by provider or by household
  Water is desalinated (17,000 desalination plants, 5% of all water consumed)
  Water was passed thru a de-osmosis filter

16) Some people decided to not participate in trial because of a health problem
  RCT particiants probably are healthier than general population
    still have gallbladder, not have gut problems, have higher vitamin D levels, etc.

17) Trial used too low of a Vitamin D threshold (typically 30 ng)
  up to 150 ng may be needed
     Will notice little benefit if a disease needs 50 ng, but trial had a goal of only 30 ng

18) Trial used vitamin D measurements from a variety of testers

See also Vitamin D Life

• Vitamin D Random Controlled Trials are becoming impossible
• More than 16 reasons why Vitamin D trials fail – Oct 2020
• Vitamin D and RCTs (Randomized Controlled Trials)
• Intervention - Vitamin D has 842 studies - more than half of which are NOT RCT
• Several more Vitamin D analyses fail to consider dose size, duration, etc. – Dec 2013
• Is it ethical to NOT give vitamin D in osteoporosis trials– NEJM Sept 2010 many years ago!
• National Osteoporosis Society of UK declares that 12 ng of vitamin D is enough – June 2013
  • Example of the many ways that researchers are rewarded for showing that (a tiny amount) of vitamin D does not provide a benefit
• Clinical Trials of vitamin D can have “biological flaws” – Jan 2015
  • Even if many RCT show benefits AND many subsequent (meta-analyses conclude that there is a benefit, the doctors often ignore them
  • Example: Colorectal cancer 40 percent less likely if 1000 IU more Vitamin D – 21st meta-analysis – Oct 2021
  • Example: Vitamin D and fractures – 24 meta-analyses and counting – Dec 2014

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