Failure of this trial was predicted by VitaminDWiki in 2016
The control group had a surprisingly high level of vitamin D (30.8 ng)
The Vitamin D supplementation raised the level to 46 ng
The D-Health Trial: a randomised controlled trial of the effect of vitamin D on mortality
The Lancet Diabetes & Endocrinology Jan 2022 https://doi.org/10.1016/S2213-8587(21)00345-4
ProfRachel ENealePhDabCatherineBaxterBAaBriony DuarteRomeroBAaDonald S AMcLeodPhDacProfDallas REnglishPhDdeProfBruce KArmstrongD PhilfgProfPeter REbelingMDhGunterHartelPhDaProfMichael GKimlinPhDiRachelO'ConnellPhDjJolieke Cvan der PolsPhDkProfAlison JVennPhDlProfPenelope MWebbD PhilabProfDavid CWhitemanPhDabMaryWaterhousePhDa
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.
Funding
The D-Health Trial is funded by National Health and Medical Research Council.
VitaminDWiki - Mortality starts with:
People die sooner if they have low vitamin D
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- Maternal pregnancy problems if Vitamin D is less than 40 ng – meta-analysis Oct 2022
- COVID-19 mortality extrapolates to zero at 50 ng of vitamin D – 18th Meta-analysis Sept 2021
- Deaths from many types of Cancer associated with low vitamin D- review of meta-analyses Sept 2020
- Cardiovascular death 1.5X more likely if less than 20 ng of Vitamin D – 22nd meta-analysis Nov 2019
- People supplemented with Vitamin D had 13 percent fewer Cancer deaths – Meta-analysis of RCT June 2019
- Cancer with low Vitamin D increases Mortality by 13 percent – meta-analysis Feb 2019
- Low Vitamin D is associated with dying sooner (70 studies) – meta-analysis Jan 2019
- Prostate Cancer death 40 percent less likely if 40 ng level of vitamin D – Meta-analysis Oct 2018
- Review of meta-analyses of non-skeletal benefits of vitamin D (Mortality, RTI, etc) – July 2017
- Chronic Kidney Disease mortality is 60 percent less likely if good vitamin D – meta-analysis July 2017
- Lung Cancer death 60 percent less likely if high level of vitamin D – 2 meta-analysis 2017
- Breast Cancer Mortality reduced 60 percent if more than 60 ng of Vitamin D – meta-analysis June 2017
- Cardiovascular deaths 12 percent less likely if have 10 ng more vitamin D – meta-analysis March 2017
- ICU patients 30 percent less likely to die if have enough vitamin D – meta-analysis Nov 2016
- Less likely to die if have enough vitamin D - Meta-analysis June 2014
- Cancer survival 4 percent more likely with just a little more vitamin D (4 ng) - meta-analysis July 2014
- Death due to breast cancer reduced 40 percent if high vitamin D – meta-analysis April 2014
- Vitamin D reduces risk of cause specific death, unless it is D2 – meta-analysis BMJ April 2014
- More survive Breast Cancer if more vitamin D – 2X fewer deaths with just 30 ng -meta-analysis March 2014
- Colorectal and Breast Cancer – Vitamin D is associated with fewer deaths – meta-analysis Feb 2014
- Death of women from cancer 24 percent less likely if 20 ng more vitamin D – meta-analysis Sept 2013
- Chance of dying increases by 25 percent in seniors if low vitamin D – Meta-analysis July 2013
- Breast Cancer survival 2X more likely if vitamin D sufficient – meta-analysis May 2013
- Vitamin D with Calcium reduces mortality by 7 percent – meta-analysis May 2012
- Death rate reduced 8 percent for 8 nanogram more vitamin D – meta-analysis Feb 2012
- 40 ng Vitamin D perhaps optimal for reduced mortality – Meta-analysis Jan 2012
- Vitamin D3 but not D2 reduces mortality – meta-analysis July 2011
- Vitamin D and mortality a meta-analysis of RCT - 2008
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- Dr. Grant on vitamin D and mortality in VitaminDWiki
- Top 10 causes of death - low vitamin D is associated with every cause - Nov 2018
- Taking vitamin D extends life - 56 trials with 100,000 people - Dr. Greger video July 2016
- Mortality reduced by 35 percent if everyone had 50 ng of vitamin D - Grant Oct 2021
- 40 percent less likely to die if vitamin D was prescribed (10,000 VA patients, no surprise) – Oct 2021
- Live longer if have more than 40 ng of Vitamin D (gene analysis of 10,500 people) – Jan 2019
- Vitamin D - at least 4,000 IU to achieve 40-60 ng and reduce risk of early death – Holick June 2018
- this study was previously announced Monthly 60,000 IU of Vitamin D did not reduce mortality (too infrequent)- Feb 2022monthly) will reduce mortality – results due 2024
VitaminDWiki - 50,000 IU every two weeks fights all of the following
Diabetes + Heart Failure + Chronic Pain + Depression + Autism + Breast Cancer + Colon Cancer + Prostate Cancer + BPH (prostate) + Preeclampsia + Premature Birth + Falls + Cognitive Decline + Respiratory Tract Infection + Influenza + Tuberculosis + Chronic Obstructive Pulmonary Disease + Lupus + Inflammatory Bowel Syndrome + Urinary Tract Infection + Poor Sleep + Growing Pain + Multiple Sclerosis + PMS + Schizophrenia + Endometriosis + Smoking 27 problems
Note: Once a week also fights: COVID, Headaches, Colds, Fibromyalgia, Asthma, Hives, Colitis etc.
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