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Why 100,000 IU of vitamin D monthly did not reduce Cardiovascular Disease – RCT April 2017

Effect of Monthly High-Dose Vitamin D Supplementation on Cardiovascular Disease in the Vitamin D Assessment Study, A Randomized Clinical Trial

JAMA Cardiol. Published online April 5, 2017. doi:10.1001/jamacardio.2017.0175
Robert Scragg, MBBS, PhD1; Alistair W. Stewart, BSc1; Debbie Waayer, MEd1; et al Carlene M. M. Lawes, MBChB, PhD1; Les Toop, MBChB, MD2; John Sluyter, PhD1; Judy Murphy, RN1; Kay-Tee Khaw, MBBChir, MSc3; Carlos A. Camargo Jr, MD, DrPH4

VitaminDWiki
  1. 4 years ago VitaminDWiki determined that monthly dosing is too infrequent
    The study on this page, using monthly dosing, was started a year before that
  2. This study failed to include Vitamin K2 – which cleans blood vessels
  3. This study failed to include Magnesium – which cleans blood vessels
  4. This study failed to include Omega-3 – which prevents clogging of blood vessels
  5. It is likely that the blood measurements of vitamin D were too near to the time of taking the monthly supplement
      – thus giving an artificially high reading (testing should not occur in less than 5 days)

See also VitaminDWiki

Cardiovascular category shows that there are many heart problems that vitamin D helps with

507 items In Cardiovascular category

Cardiovascular category is associated with other categories: Diabetes 31, Omega-3 31 , Vitamin K 25 , Intervention 22 . Mortality 20 , Skin - Dark 18 , Magnesium 17 , Calcium 14 , Hypertension 14 , Trauma and surgery 13 , Stroke 13 , Kidney 12 , Metabolic Syndrome 11 , Seniors 10 , Pregnancy 8 as of Aug 2022


Cholesterol, Statins

 Download the PDF from VitaminDWiki

Key Points

  • Question Does monthly high-dose vitamin D supplementation prevent cardiovascular disease?
  • Findings In a randomized clinical trial that included 5108 participants from the community, the cumulative incidence of cardiovascular disease for a median follow-up period of 3.3 years was 11.8% among participants given 100 000 IU of vitamin D3 monthly and 11.5% among those given placebo.
  • Meaning Monthly high-dose vitamin D supplementation did not prevent cardiovascular disease and should not be used for this purpose.


Abstract
Importance Cohort studies have reported increased incidence of cardiovascular disease (CVD) among individuals with low vitamin D status. To date, randomized clinical trials of vitamin D supplementation have not found an effect, possibly because of using too low a dose of vitamin D.

Objective To examine whether monthly high-dose vitamin D supplementation prevents CVD in the general population.

Design, Setting, and Participants The Vitamin D Assessment Study is a randomized, double-blind, placebo-controlled trial that recruited participants mostly from family practices in Auckland, New Zealand, from April 5, 2011, through November 6, 2012, with follow-up until July 2015. Participants were community-resident adults aged 50 to 84 years. Of 47 905 adults invited from family practices and 163 from community groups, 5110 participants were randomized to receive vitamin D3 (n = 2558) or placebo (n = 2552). Two participants retracted consent, and all others (n = 5108) were included in the primary analysis.

Interventions Oral vitamin D3 in an initial dose of 200 000 IU, followed a month later by monthly doses of 100 000 IU, or placebo for a median of 3.3 years (range, 2.5-4.2 years).

Main Outcomes and Measures The primary outcome was the number of participants with incident CVD and death, including a prespecified subgroup analysis in participants with vitamin D deficiency (baseline deseasonalized 25-hydroxyvitamin D [25(OH)D] levels <20 ng/mL). Secondary outcomes were myocardial infarction, angina, heart failure, hypertension, arrhythmias, arteriosclerosis, stroke, and venous thrombosis.

Results Of the 5108 participants included in the analysis, the mean (SD) age was 65.9 (8.3) years, 2969 (58.1%) were male, and 4253 (83.3%) were of European or other ethnicity, with the remainder being Polynesian or South Asian. Mean (SD) baseline deseasonalized 25(OH)D concentration was 26.5 (9.0) ng/mL, with 1270 participants (24.9%) being vitamin D deficient. In a random sample of 438 participants, the mean follow-up 25(OH)D level was greater than 20 ng/mL higher in the vitamin D group than in the placebo group. The primary outcome of CVD occurred in 303 participants (11.8%) in the vitamin D group and 293 participants (11.5%) in the placebo group, yielding an adjusted hazard ratio of 1.02 (95% CI, 0.87-1.20). Similar results were seen for participants with baseline vitamin D deficiency and for secondary outcomes.

Conclusions and Relevance Monthly high-dose vitamin D supplementation does not prevent CVD. This result does not support the use of monthly vitamin D supplementation for this purpose. The effects of daily or weekly dosing require further study.

Trial Registration clinicaltrials.gov Identifier: ACTRN12611000402943

Attached files

ID Name Comment Uploaded Size Downloads
7892 100,000 monthly raised 20 ng.pdf admin 05 Apr, 2017 385.43 Kb 1786