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
click on image for details
- More vitamin D means fewer deaths – many studies
- Much more likely to live longer if higher vitamin D – 27,000 seniors Feb 2017
- 2,000 IU of Vitamin D daily to German Seniors would save 30,000 lives a year – March 2021
- 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
- Much more likely to live longer if higher vitamin D – 27,000 seniors Feb 2017
- Low Vitamin D is associated with dying sooner (70 studies) – meta-analysis Jan 2019
- 4.8 X more likely to die within 28 days of ICU if low Vitamin D - Jan 2024
- Chance of dying in hospital cut in half by just 10 ng higher level of Vitamin D – April 2016
- Senior women having low vitamin D were 2X more likely to die - Sept 2023
- Risk of death after bone fracture was 6.6 X higher if less than 10 ng of vitamin D – June 2017
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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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