How to Understand, Refute, and Plan Studies Using Vitamin D

A forum to discuss the Coimbra Protocol which uses high-dose vitamin D3 to treat multiple sclerosis.

How to Understand, Refute, and Plan Studies Using Vitamin D

Postby AntonioBR » Fri Apr 14, 2017 9:33 am



How to Understand, Refute, and Plan Studies Using Vitamin D


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[...]
Defining the problems:

  • The (primary) problem: Most doctors and researchers have zero expert-level training in Nutrition (let alone Clinical Nutrition, Therapeutic/Interventional Nutrition, Functional Nutrition) and therefore the studies they design using vitamin D are methodologically flawed, as described below.
  • The (secondary) problem: Too many studies using vitamin D (cholecalciferol) have used vitamin D in 1) doses that are inadequate, 2) for durations that are inadequate, and thus these studies are therapeutically underpowered, tending to lead to lackluster or negative (inefficacious) results, thereby leading to the false conclusion that vitamin D is ineffective when in fact it either is or might be effective.
  • The (tertiary) problem: As a result of therapeutically underpowered studies, too many research articles paint a false picture of inefficacy when in fact vitamin D is or may be highly efficacious; as a result, patients are denied a safe and effective therapeutic route that offers low-cost efficacy, high safety, and numerous collateral benefits.
  • The (quaternary) problem: Another major problem is that too many doctors and researchers are unaware of the major paradigm-shifting studies that should have resulted in major acceptance of vitamin D utilization in preventive public health and clinical medicine; as a result of this ignorance, too many research projects are essentially starting from zero or a very shallow foundation rather than progressively building on a foundation of good science and appropriate pattern recognition. Researchers who have not studied the history of nutrition and the decades of literature are essentially ignorant of the history and direction of the field into which they enter; one can be amused by the prospect of a researcher placed in a position of authority to shape and define the direction of a field which he/she has never studied, ie, many researchers wear no clothes.

[...]

  1. Did the study subjects receive at least 3,000-10,000 IU per day?
    If not, then the study likely used inadequate dosage to produce optimal physiologic effects.
  2. Is the duration of the study at least 6-9 months?
    If not, then body stores of vitamin D were likely not replaced in time for clinical effect to take place.
  3. Did the study use vitamin D3 (cholecalciferol) rather than fungally-derived erogcalciferol?
    Ergocalciferol is not a human nutrient, and it is more toxic and less effective than is cholecalciferol.
  4. Was the product validated for potency?
    If not, then the intervention may have failed due to an erroneously produced or falsely labeled product.
  5. Were serum 25-OH-vitamin D levels measured?
    If not, the product potency and nutrient absorption were not ensured.
  6. Did serum 25-OH-vitamin D levels enter the optimal range at least 3-6 months before the end of the study?
    If not, then the patients may have been vitamin D deficient for the entire duration of the study.
  7. Were the patients deficient at the start of the study and then robustly replaced with vitamin D?
    If not, then "deficiency => deficiency" is not a competent study design and intervention, nor is "replete => replete." The appropriate intervention is to change deficiency to repletion.
  8. Vitamin D supplementation should be stopped for roughly 20-30 days before serum testing because 25-hydroxyvitamin D3 (calcidiol) has a half-life of 15 days. The goal with serum testing of 25-OH-vitamin D levels is to assess tissue saturation, not acute absorption. Testing vitamin D serum levels within a few days of vitamin D supplementation is more likely to reflect absorption and hepatic conversion rather than providing the more important and more accurate assessment of vitamin D tissue stores.
  9. Obviously, clinical trials need to control for factors that increase vitamin D status (eg, sun exposure, fish oil especially cod liver oil) and those which promote vitamin D deficiency, especially antiseizure drugs, cholestyramine.



Full Article: http://www.ichnfm.org/d
AntonioBR
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Joined: Sat Dec 12, 2015 11:06 am

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