Vitamin D Consenus

A place to get your questions answered from McDougall staff dietitian, Jeff Novick, MS, RDN.

Moderators: JeffN, carolve, Heather McDougall

Re: Vitamin D Consenus

Postby JeffN » Wed Jan 12, 2022 10:30 am

The Lancet Diabetes and Endocrinology
The D-Health Trial: a randomised controlled trial of the effect of vitamin D on mortality
Published:January 10, 2022DOI:https://doi.org/10.1016/S2213-8587(21)00345-4
PlumX Metrics

Summary

Background

The effect of supplementing unscreened adults with vitamin D3 on mortality is unclear. We aimed to determine whether monthly doses of vitamin D3 influenced mortality in older Australians.
Methods

We did a randomised, double-blind, placebo-controlled trial of oral vitamin D3 supplementation (60 000 IU per month) in Australians 60 years or older who were recruited across the country via the Commonwealth electoral roll. Participants were randomly assigned (1:1), using automated computer-generated permuted block randomisation, to receive one oral gel capsule of either 60 000 IU vitamin D3 or placebo once a month for 5 years. Participants, staff, and investigators were blinded to study group allocation. The primary endpoint was all-cause mortality assessed in all participants who were randomly assigned. We also analysed mortality from cancer, cardiovascular disease, and other causes. Hazard ratios (HRs) and 95% CIs were generated using flexible parametric survival models. This trial is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12613000743763.
Findings

Between Feb 14, 2014, and June 17, 2015, we randomly assigned 21 315 participants, including 10 662 to the vitamin D group and 10 653 to the placebo group. In 4441 blood samples collected from randomly sampled participants (N=3943) during follow-up, mean serum 25-hydroxy-vitamin D concentrations were 77 (SD 25) in the placebo group and 115 (SD 30) nmol/L in the vitamin D group. Following 5 years of intervention (median follow-up 5·7 years [IQR 5·4–6·7]), 1100 deaths were recorded (placebo 538 [5·1%]; vitamin D 562 [5·3%]). 10 661 participants in the vitamin D group and 10 649 participants in the placebo group were included in the primary analysis. Five participants (one in the vitamin D group and four in the placebo group) were not included as they requested to be withdrawn and their data to be destroyed. The HR of vitamin D3 effect on all-cause mortality was 1.04 [95% CI 0·93 to 1·18]; p=0·47)and the HR of vitamin D3 effect on cardiovascular disease mortality was 0·96 (95% CI 0·72 to 1·28; p=0·77). The HR for cancer mortality was 1·15 (95% CI 0·96 to 1·39; p=0·13) and for mortality from other causes it was 0·83 (95% CI 0·65 to 1·07; p=0·15). The odds ratio for the per-protocol analysis was OR 1·18 (95% CI 1·00 to 1·40; p=0·06). In exploratory analyses excluding the first 2 years of follow-up, those randomly assigned to receive vitamin D had a numerically higher hazard of cancer mortality than those in the placebo group (HR 1·24 [95% CI 1·01–1·54]; p=0·05).
Interpretation

Administering vitamin D3 monthly to unscreened older people did not reduce all-cause mortality. Point estimates and exploratory analyses excluding the early follow-up period were consistent with an increased risk of death from cancer. Pending further evidence, the precautionary principle would suggest that this dosing regimen might not be appropriate in people who are vitamin D-replete.
User avatar
JeffN
 
Posts: 9412
Joined: Tue Jan 08, 2008 5:56 am

Re: Vitamin D Consenus

Postby JeffN » Fri Feb 04, 2022 10:21 am

Adjusting to ng/ml, which is more commonly used in this thread....

"A study among 472 people hospitalized with COVID in the UK found that, after adjusting for age, sex and comorbidities, the risk of death at 28 days was 137% higher for those who were vitamin D defcient (25(OH)D of < 10 ng/mL), and 365% higher for those with a vitamin D level at or above 40 ng/mL, compared to those with blood levels between about 20 and 30 ng/mL The increased risk at lowest and highest blood levels of vitamin D follows a similar pattern seen with risk of mortality in general and with other adverse effects for vitamin D."


Study...

Vitamin D, D-binding protein, free vitamin D and COVID-19 mortality in hospitalized patients
The American Journal of Clinical Nutrition, nqac027, https://doi.org/10.1093/ajcn/nqac027
Published: 31 January 2022

https://academic.oup.com/ajcn/advance-a ... 27/6518440

Abstract

Background
Vitamin D deficiency has been associated with worse coronavirus disease 2019 (COVID-19) outcomes but circulating 25-hydroxyvitamin D (25(OH)D) is largely bound to vitamin D binding protein (DBP) or albumin both of which tend to fall in illness making 25(OH)D status hard to interpret. Because of this, measurement of unbound “free” and albumin-bound “bioavailable” 25(OH) D has been proposed.

Objective
We aimed to examine the relationship between vitamin D status and mortality from COVID-19.

Methods
In this observational study conducted in Liverpool, UK, hospitalized COVID-19 patients with surplus sera available for 25(OH)D analysis were studied. Clinical data including age, ethnicity and co-morbidities were extracted from case notes. Serum 25(OH)D, DBP and albumin concentrations were measured. Free and bioavailable 25(OH) D were calculated. Relationships between total, free and bioavailable 25(OH)D and 28-day mortality were analyzed by logistic regression.

Findings
Four hundred and seventy-two patients with COVID-19 were included, of whom 112 (23.7%) died within 28 days. Non-survivors were older (mean age 73, [range 34-98]) than survivors (65, [19-95]; P = 0.003) and more likely male (67%; P = 0.02). The frequency of vitamin D deficiency (25(OH)D <50nmol/L) was similar between non-survivors (71/112 [63.4%]) and survivors (204/360 [56.7%]; P = 0.15) but, after adjustment for age, sex and co-morbidities, increased odds for mortality were present in those with severe deficiency (25(OH)D <25nmol/L), OR 2.37 (95% CI 1.17, 4.78), or high 25(OH)D (≥100nmol/L), OR 4.65 (95% CI 1.51, 14.34) compared with 25(OH)D 50-74 nmol/L (reference). Serum DBP levels were not associated with mortality after adjustment for 25(OH)D, age, sex and co-morbidities. Neither free nor bioavailable 25(OH)D were associated with mortality.

Conclusion
Vitamin D deficiency as commonly defined by serum 25 (OH)D levels (<50nmol/L) is not associated with increased mortality from COVID-19 but extreme low (<25nmol/L) and high (>100nmol/L) levels may be associated with risk. Neither free nor bioavailable 25(OH) D associate with risk.
User avatar
JeffN
 
Posts: 9412
Joined: Tue Jan 08, 2008 5:56 am

Re: Vitamin D Consenus

Postby JeffN » Thu Jul 28, 2022 6:24 am

ORIGINAL ARTICLE FREE PREVIEW
Supplemental Vitamin D and Incident Fractures in Midlife and Older Adults
July 28, 2022
N Engl J Med 2022; 387:299-309
DOI: 10.1056/NEJMoa2202106
Abstract

BACKGROUND
Vitamin D supplements are widely recommended for bone health in the general population, but data on whether they prevent fractures have been inconsistent.

METHODS
In an ancillary study of the Vitamin D and Omega-3 Trial (VITAL), we tested whether supplemental vitamin D3 would result in a lower risk of fractures than placebo. VITAL was a two-by-two factorial, randomized, controlled trial that investigated whether supplemental vitamin D3 (2000 IU per day), n−3 fatty acids (1 g per day), or both would prevent cancer and cardiovascular disease in men 50 years of age or older and women 55 years of age or older in the United States. Participants were not recruited on the basis of vitamin D deficiency, low bone mass, or osteoporosis. Incident fractures were reported by participants on annual questionnaires and adjudicated by centralized medical-record review. The primary end points were incident total, nonvertebral, and hip fractures. Proportional-hazards models were used to estimate the treatment effect in intention-to-treat analyses.

RESULTS
Among 25,871 participants (50.6% women [13,085 of 25,871] and 20.2% Black [5106 of 25,304]), we confirmed 1991 incident fractures in 1551 participants over a median follow-up of 5.3 years. Supplemental vitamin D3, as compared with placebo, did not have a significant effect on total fractures (which occurred in 769 of 12,927 participants in the vitamin D group and in 782 of 12,944 participants in the placebo group; hazard ratio, 0.98; 95% confidence interval [CI], 0.89 to 1.08; P=0.70), nonvertebral fractures (hazard ratio, 0.97; 95% CI, 0.87 to 1.07; P=0.50), or hip fractures (hazard ratio, 1.01; 95% CI, 0.70 to 1.47; P=0.96). There was no modification of the treatment effect according to baseline characteristics, including age, sex, race or ethnic group, body-mass index, or serum 25-hydroxyvitamin D levels. There were no substantial between-group differences in adverse events as assessed in the parent trial.

CONCLUSIONS
Vitamin D3 supplementation did not result in a significantly lower risk of fractures than placebo among generally healthy midlife and older adults who were not selected for vitamin D deficiency, low bone mass, or osteoporosis. (Funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases; VITAL ClinicalTrials.gov number, NCT01704859. opens in new tab.)



Study Finds Another Condition That Vitamin D Pills Do Not Help
The vitamin pills do not prevent bone fractures in most people or protect against many other diseases, adding to questions about medical guidance many now take for grante

https://www.nytimes.com/2022/07/27/heal ... tures.html
User avatar
JeffN
 
Posts: 9412
Joined: Tue Jan 08, 2008 5:56 am

Re: Vitamin D Consenus

Postby JeffN » Fri Mar 24, 2023 2:23 pm

JeffN wrote:Vitamin D: What is the right level?


This first article highlights a point about RDA/DRI's that I have discussed here before. They are not individual requirements but populations goals and most of us can do fine if we just average ~70%)

Vitamin D Deficiency — Is There Really a Pandemic?
NEJM 375;19 nejm.org November 10, 2016

https://www.nejm.org/doi/10.1056/NEJMp1608005

"A common misconception is that the RDA functions as a “cut point” and that nearly the entire population must have a serum 25(OH)D level above 20 ng per milliliter to achieve good bone health. The reality is that the majority (about 97.5%) if the population has a requirement of 20 ng per milliliter or less. Moreover, by definition of an average requirement, approximately half the population has a requirement of 16 ng per milliliter (the EAR) or less. . These concepts are depicted in the population reference-value distribution shown in Panel A, which highlights the relationship between the EAR and the RDA.

In creating its framework for reference values, the IOM anticipated the inherent variability in nutrient requirements and there- fore established — and verified by statistical modeling4 — the goal of achieving population levels above the EAR, not the RDA. However, the literature is replete with misapplications of the RDA that treat it as a cut point. Many studies establish “inadequacy” using the RDA, though it is actually at the upper end of the spectrum of human need. Clearly, this approach misclassifies as “deficient” most people whose nutrient requirements are being met — thereby creating the appearance of a pandemic of deficiency.

Applying the correct method to data from the National Health and Nutrition Examination Survey (NHANES) for 2007 through 2010 reveals that 13% of Americans 1 to 70 years of age are “at risk” for vitamin D inadequacy. Less than 6% are deficient in vitamin D [serum 25(OH)D levels <12.5 ng per milliliter4]. The utility of measurement of parathyroid hormone (PTH) concentrations for identifying the optimal level of vitamin D remains controversial; the relationship between serum 25(OH)D and PTH is inconsistent, and no clear threshold defining “sufficiency” has been established.4 Vitamin D is a nutrient of concern, but these levels of deficiency do not constitute a pandemic.

Furthermore, using the RDA- associated serum concentrations of vitamin D to judge whether population groups have inadequate levels or to set intake goals for populations inflates the estimated prevalence of inadequacy and overestimates the needed in- take. Indeed, ensuring that 97.5% of the population attains or exceeds vitamin D levels of 20 ng per milliliter would require shifting the entire population to a higher intake (see graph in Panel B). This misapplication of RDA-asso-ciated concentrations could cause harm to people whose intake is pushed above the Tolerable Upper IntakeLevel(UL,the level at which there may be adverse effects), which the IOM has established as 4000 IU daily with a resulting serum 25(OH)D concentration of approximately 50 ng per milliliter (125 nmol per liter). A modeling study by Taylor et al. suggested that shifting the distribution of serum 25(OH)D concentrations in adults 19 to 70 years of age upward so that the RDA-associated concentration of 20 ng per milliliter was achieved in nearly everyone (all but 2.5% of the population) would mean that levels in some people would exceed the UL"




Updated interview with the Author

HARVARD HEALTH BLOG
Vitamin D: What’s the "right" level?
April 16, 2020

https://www.health.harvard.edu/blog/vit ... 6121910893

So, who should be screened for vitamin D deficiency?

Dr. Finkelstein and his colleagues published a study of over 2,000 perimenopausal women who had been followed for almost 10 years, and they found that vitamin D levels less than 20 were associated with a slightly increased risk of nontraumatic fractures. They concluded that because few foods contain vitamin D, vitamin D supplementation is warranted in women at midlife with levels less than 20 ng/mL. "For perimenopausal women or other groups of people with higher fracture risk, certainly a level of 20 or above is ideal," and he adds: "For the vast majority of healthy individuals, levels much lower, 15, maybe 10, are probably perfectly fine, and so I would say I agree with what the authors of the New England Journal perspective article are saying."
User avatar
JeffN
 
Posts: 9412
Joined: Tue Jan 08, 2008 5:56 am

Previous

Return to Jeff Novick, RD

Who is online

Users browsing this forum: No registered users and 6 guests



Welcome!

Sign up to receive our regular articles, recipes, and news about upcoming events.