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Hypothesis - Low Vitamin D causes Cardiovascular diseases - Dec 2016

Vitamin D and cardiovascular diseases: Causality

Journal of Steroid Biochemistry & Molecular Biology, http://dx.doi.org/doi:10.1016/j.jsbmb.2016.12.016
Sunil J. Wimalawansa


Cardiovascular category starts with the following

347 items In Cardiovascular category

The Meta-analysis of Cardiovascular and Vitamin D

See also PubMed (behind paywall Serum 25-hydroxyvitamin D and the risk of cardiovascular disease: dose-response meta-analysis of prospective studies April 2017, 34 publications with 180,667 participants, 10% less likely for each 10ng higher level of vitamin D

 Download the PDF from SciHub via VitaminDWiki

Clipped from the PDF

Risk of Cardiovascular disease is less than half when Vitamin D - 30 ng



Recommendations for future RCTs

Characteristics and conditions that must be accomplished Clarifications (caveats)
RCT must be adequately powered for meaningful statistical analysis and to make conclusions Valid, statistical power analysis is essential during the designing of RCT
Participants in study groups must have the disease being studied (e.g., particular CVD); alternatively, for those with deficiency (insufficiency) researchers can determine whether or not the disease develops over the course of the study All study participants need to have hypovitaminosis D; i.e., deficiency [serum 25(OH)D levels below 20 ng/mL] or severe deficiency [levels below 10 ng/mL], depending on the disease situation
Study end point must be based on hard end points Reduction of morbidity or mortality; decreased incidence of the disease being investigated, etc.
The dose of vitamin D must be adequate for the study participants to achieve blood 25(OH)D levels greater than 30 to 40 ng/mL.* This is essential not missing the treatment effects. Some participants may need higher daily doses of vitamin D, as much as 5,000 IU/day; Caveat: Because of the feeling of well-being, it is possible that subjects may determine that they are in the treatment arm.
An alternative, practical, and cost- effective regimen is to administer oral vitamin D, 50,000 IU once a week (monitored at 3-month intervals) to achieve the desired blood 25(OH)D levels. Safety monitoring: serum and urinary calcium levels to identify hypercalcemia and hypercalciuria (very rare adverse effects at these doses).
Predetermined serum 25(OH)D levels must be achieved and maintained within the expected range; one clinic visit can be replaced with a home vitamin D testing kit For example, dose titrated to achieve serum levels to more than 30 ng/mL (75 nmol/L), with levels maintained between 30 and 50 ng/mL throughout the study (maintenance doses).
Measure 25(OH)D, serum calcium and urinary calcium levels at baseline and every 3 months; only subjects with low blood 25(OH)D concentration should be enrolled-(health outcome relationships). Assure the desired blood level is achieved and maintained within the expected range, avoiding adverse effects; alternatively, investigators could look at results as a function of baseline 25(OH)D, not dose or blood levels of 25(OH)D achieved.
Other objective measurements such as echocardiography or Brain naturetic peptide. These tests should be performed before and after the treatment period.
Trial duration of at least 2 years, preferably between 2 and 5 years. This is more feasible at institutions such as those for individuals with developmental disabilities.
However, compliance is compromised with longer durations, but this problem can be minimized by using a loading dose regimen at the onset and a smaller dose thereafter. desired serum 25(OH)D levels within the first few weeks
Some of these clinical trials could be completed by 1 year, if the protocol includes "loading doses” of vitamin D [i.e., achieving the desired serum 25(OH)D levels within the first few weeks].
Proper maintenance of blood levels throughout the study is essential.].
Proper maintenance of blood levels throughout the study is essential. The placebo group ideally should remain deficient (most people in the community otherwise will remain untreated with vitamin D). However, provision of vitamin D in a regimen of 400 IU/day is unlikely to alter the study outcomes.
Note: Cochrane rejects studies that have any amount of extra/supplementary vitamin D in the placebo group. The baseline and the achieved maintenance levels of blood 25(OH)D are more important than the vitamin D dose itself.
If the ethic committee objects, the Institute of Medicine (IOM) recommended dose could be administered in the placebo group. For example, 600 IU vitamin D per day could be given to the placebo group. However, this may interfere with the trial outcomes and statistics ,
Because the participants are likely to have concomitant nutritional deficiencies that are not detected by commonly used blood tests, both groups should be supplemented with other micronutrient supplements, such as vitamin K2, magnesium, boron, zinc, and omega-3. Some cofactors are required for paracrine effects of 25(OH)D and 1,25(OH)2D, a combination of cofactors should be administered to both the treatment and placebo groups to assure that there are no other deficiency-induced confounding effects.

Created by admin. Last Modification: Sunday December 3, 2017 21:11:23 UTC by admin. (Version 14)

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8861 S2.jpg admin 03 Dec, 2017 20:49 51.59 Kb 24
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8859 Causality Sunil 3.jpg admin 03 Dec, 2017 20:44 31.45 Kb 24
8858 Causality Sunil.pdf admin 03 Dec, 2017 20:36 826.58 Kb 15
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