Monthly High-Dose Vitamin D Treatment for the Prevention of Functional Decline, A Randomized Clinical Trial
JAMA Internal Medicine Jan 2016
Heike A. Bischoff-Ferrari, MD, DrPH1,2; Bess Dawson-Hughes, MD3; E. John Orav, PhD4; Hannes B. Staehelin, MD5; Otto W. Meyer, MD1,2; Robert Theiler, MD2; Walter Dick, MD6; Walter C. Willett, MD, DrPH7; Andreas Egli, MD1,2
1Department of Geriatrics and Aging Research, University Hospital Zurich, Zurich, Switzerland
2Centre on Aging and Mobility, University of Zurich, Zurich, Switzerland
3Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, Massachusetts
4Department of Biostatistics, Harvard T. H. Chan School of Public Health, Boston, Massachusetts
5Department of Geriatrics, University of Basel, Basel, Switzerland
6Department of Orthopedic Surgery, University of Basel, Basel, Switzerland
7Department of Nutrition, Harvard T. H. Chan School of Public Health, Boston, Massachusetts
 Download the marked up PDF from VitaminDWiki
The study was unable to find an expected conclusion (that more Vitamin D ==> reduces falls), so did a secondary analysis
The study ignored many factors during randomization and/or secondary analysis
- Which people were taking drugs for fall prevention
- Which people were taking high blood pressure medication – which increases falls
- The cause of the falls – dizziness, poor sight, poor muscle strength, slow muscle response
- Number of previous falls (study ignored if person had 1 fall or 10 falls in the previous year)
- All falls were considered to be the same.
Whereas some falls make a person more likely to have further falls - BMI (unless grossly obese)
BMI unreported in subsequent high vs low grouping secondary analysis
Highly likely that those with high BMI had low vitamin D levels, were less active, and were less likely to fall - METs/month were not reported for the secondary analysis.
It is likely that less active ==> less likely to fall
In addition: Strangely
- There did not seem to be ANY fractures resulting from the falls
No falls were reported and everyone was able to make the final office visit - Entire 12 months of falling were considered – even though vitamin D levels not raised much during first 3 months
Note – study did not even measure the 3 month levels. - The study clipped the fall rate – treating number of falls > 5 as =5.
This truncation greatly distorts the data - The same authors published a study 7 years before showing the exact opposite - that 2,000 IU did reduce falls
See VitaminDWiki 39% fewer falls with 2000 IU than 800 IU – RCT June 2010
Note also:
- This was such a small study that it discarded those who were not willing to reduce to only 800 IU of vitamin D
- Vitamin D reduces FALLS by improving muscle response speed
Perhaps montly dosing is too infrequent to improve muscle response speed - no data, no hints - Vitamin D reduces FRACTURES by improving bone strength
- Since there was no control group, the study ended up, in secondary analysis, with having to compare responders to none/poor responders
See also VitaminDWiki
258 items in FALLS and FRACTURES - Overview Fractures and Falls and Vitamin D
- Vitamin D prevents falls – majority of meta-analyses conclude – meta-meta analysis Feb 2015
- Rate of falls reduced 2X by just 1000 IU of vitamin D – RCT Nov 2015
- 800 IU of vitamin D does not prevent enough falls to be cost effective - July 2015
See also GrassrootsHealth Controversy- Jan 2016
The following table is extracted from the above image, so that text can be found and translated1. Basal nutrient status must be measured, used as an inclusion criterion for entry into study, and recorded in the report of the trial. QUESTIONABLE.
Baseline 25(OH)D levels were measured and reported but were not used as inclusion criterion (58% were <20 ng/ml at baseline). Some analyses were limited to those with baseline levels <20 ng/ml (but these analyses compared treatment groups, not achieved serum level groups).2. The intervention (i.e., change in nutrient exposure or intake) must be large enough to change nutrient status and must be quantified by suitable analyses. DID MEET (WITH NOTES).
There were three groups: 24000 IU/month (~800 IU/day; control group), 60000 IU/month (~2000IU/day), and 24000 IU/month plus 300 ug/month calcifediol. These dose amounts were large enough to produce a change in nutrient status.Notes: While not measured with 25(OH)D, infrequent dosing of the parent compound, D3, may have influenced the results.3. The change in nutrient status produced in those enrolled in the trials must be measured and recorded in the report of the trial. DID MEET.
25(OH)D concentrations were measured and recorded at 6 and 12 months.4. The hypothesis to be tested must be that a change in nutrient status (not just a change in intake) produces the sought-for effect. DID MEET.
While the hypothesis was that higher monthly doses of vitamin D would reduce the risk of functional decline, findings were also reported by achieved serum level.5. Co-nutrient status must be optimized in order to ensure that the test nutrient is the only nutrition-related, limiting factor in the response. DID NOT MEET.
Data about other nutrients do not appear to have been collected or reported (e.g. calcium, magnesium, vitamin K, etc.). The maximum calcium supplement dose allowed was 250 mg/day, much lower than the IOM recommendation of 1200 mg/day. Calcium, an essential co-nutrient for bone health, does not appear to be optimized.References:
- 1Guidelines for optimizing design and analysis of clinical studies of nutrient effects, Heaney RP, December 2013.
- 2Monthly High-Dose Vitamin D Treatment for the Prevention of Functional Decline, Bischoff-Ferrari et al., January 2016.
Editorial on the study went on to claim that Vitamin D should not be used for anything
Clipped from PDF
"Clinicians should not recommend vitamin D supplements for other putative health benefits. There is no evidence from meta-analyses of RCTs that vitamin D supplementation reduces the risk of cardiovascular disease or cancer.13,18 In addition, a recent trial19 found that 1000 IU of vitamin D per day, with or without calcium, did not decrease the risk of colon cancer or recurrent adenomas in those with a history of colon adenomas."
 Download the PDF from VitaminDWikiThe editorial ignores many published meta-analyses - which can be found in VitaminDWiki
The Meta-analysis of CANCER and Vitamin D
- USPSTF says no evidence that Vitamins prevent CVD or Cancer (data disagrees) Aug 2022
- Deaths from many types of Cancer associated with low vitamin D- review of meta-analyses Sept 2020
- Vitamin D fights 13 cancers – review of 35 meta-analyses – Oct 2020
- People supplemented with Vitamin D had 13 percent fewer Cancer deaths – Meta-analysis of RCT June 2019
- Non-Hodgkin Lymphoma 20 percent more likely if low UV – meta-analysis April 2019
- Cancer with low Vitamin D increases Mortality by 13 percent – meta-analysis Feb 2019
- Cancer not treated by Vitamin D when ignore dose size, type, and length of trial – meta-analysis April 2018
- Risk of Cancer increased if poor Vitamin D Receptor – meta-analysis of 73 studies Jan 2016
- Cancer risk weakly associated with vitamin D-binding protein – meta-analysis Sept 2015
- Obesity causes 20 percent of all cancer, low vitamin D may be the connection – meta-analysis - Sept 2014
- Cancer survival 4 percent more likely with just a little more vitamin D (4 ng) - meta-analysis July 2014
- Vitamin D receptor polymorphisms are risk factors for various cancers – meta-analysis Jan 2014
- Death of women from cancer 24% less likely if 20 ng more vitamin D – meta-analysis Sept 2013
- Probably need more than 1000 IU of vitamin D to prevent cancer – meta-analysis Aug 2013
- Vitamin D has a complex relationship with Cancer – meta-analysis July 2011
- Meta-analysis of 3 cancers - 10 ng more vitamin D decrease colorectal by 15 percent– May 2010
The Meta-analysis of Breast Cancer and Vitamin D
- Analysis of 280 Breast Cancer meta-analyses: having low vitamin D was highly suggestive – umbrella July 2024
- Breast Cancer not prevented by vitamin D when use small doses or for just a short time – Meta-analysis April 2023
- Breast Cancer risk - meta-analysis of 50 studies - Dec 2019
- Deaths from many types of Cancer associated with low vitamin D- review of meta-analyses Sept 2020
- Breast Cancer again associated with low vitamin D – 15th meta-analysis Sept 2020
- Breast Cancer risk reduced 17 percent by 1 hour of daily summer sun – meta-analysis Jan 2020
- Breast Cancer reduced 20 percent by fish (Omega-3) – meta-analysis Feb 2019
- Breast Cancer rate reduced by 40 percent with Omega-3 – meta-analysis June 2013
- Breast Cancer Mortality reduced 60 percent if more than 60 ng of Vitamin D – meta-analysis June 2017
- Increased risk of some female cancers if low vitamin D (due to genes) – meta-analysis June 2015
- Cancer (colon, breast, lymph) survival about 2X better with high level vitamin D – meta-analysis July 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
- 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
- Breast Cancer – review of 2 RCT did not find association with 1000 IU of Vitamin D – July 2013
- Breast Cancer post menopause down 12 percent for every 5 ng of vitamin D – meta-analysis May 2013
- 3.2 percent less Breast Cancer for 2.4 ng more vitamin D – meta-analysis June 2013
- Breast Cancer survival 2X more likely if vitamin D sufficient – meta-analysis May 2013
- Graphs of Vitamin D and Cancer – meta-analysis Dec 2011
- Meta-analysis not find low vitamin D years before breast cancer – Aug 2010
- Meta-analysis confirmed that vitamin D and calcium prevents breast cancer – June 2010
- Meta-analysis found vitamin D association with colon but not prostate nor breast cancer May 2010
- Breast cancer association with low vitamin D suggested by Meta-analysis -April 2010
- Meta-analysis did not find strong association between vitamin D and breast cancer risk -April 2010
The Meta-analysis of Colon Cancer and Vitamin D
- 16 factors increase the risk of early-onset colorectal cancer, only vitamin D decreases the risk – meta-analysis May 2023
- Colorectal Cancer 10 percent more likely if poor Vitamin D Receptor – meta-analysis Jan 2023
- Colorectal cancer 14 percent less likely if 10 ng more Vitamin D – 22nd meta-analysis – Sept 2022
- Colorectal cancer 40 percent less likely if 1000 IU more Vitamin D – 21st meta-analysis – Oct 2021
- Colorectal cancer 25 percent less likely if good level of Vitamin D – 20th meta-analysis – June 2021
- Deaths from many types of Cancer associated with low vitamin D- review of meta-analyses Sept 2020
- Colorectal cancer treated by Vitamin D – 19th meta-analysis – Sept 2020
- Colon cancer both prevented and treated by Vitamin D – meta-analysis Dec 2019
- Colorectal cancer is associated with Vitamin D (17 meta-analyses so far) – July 2018
- Colorectal cancer 60 percent less likely: high vs low Vitamin D level – meta-analysis Dec 2016
- Colorectal Cancer recurrence not prevented by 1,000 IU of vitamin D – meta-analysis Dec 2016
- Risk of Cancer increased if poor Vitamin D Receptor – meta-analysis of 73 studies Jan 2016
- Colon cancer 30 percent more likely if low vitamin D – 12th meta-analysis Aug 2015
- Colon cancer risk reduced by many vitamins – 13 percent reduction by Vitamin D – meta-analysis Jan 2015
- Cancer (colon, breast, lymph) survival about 2X better with high level vitamin D – meta-analysis July 2014
- Cancer survival 4 percent more likely with just a little more vitamin D (4 ng) - meta-analysis July 2014
- Colorectal and Breast Cancer – Vitamin D is associated with fewer deaths – meta-analysis Feb 2014
- 10 percent of colon cancer linked to Vitamin D Receptor – meta-analysis April 2012
- Graphs of Vitamin D and Cancer – meta-analysis Dec 2011
- Colon cancer probability increases with decreased vitamin D – Meta-analysis July 2011
- Non-cancer colon growths 7 % less likely per 10 ng increase in Vitamin D – Oct 2011
- Colorectal cancer 26 percent less likely for every 10 ng of vitamin D – meta-analysis Aug 2011
- Colon polyps reduced 15 percent by increasing vitamin D by 20 ng – meta-analysis June 2011
- Meta-analysis of 3 cancers - 10 ng more vitamin D decrease colorectal by 15 percent– May 2010
- Meta-analysis found vitamin D association with colon but not prostate nor breast cancer May 2010
The Meta-analysis of Falls/Fractures
- No increase in falls, fractures or all-cause mortality when Vitamin D is given monthly or less often– meta-analysis April 2024
- 100,000 IU of Vitamin D monthly (27 ng) is not enough to reduce fractures and falls – meta-analysis April 2024
- Increased risk of fracture if high level of Vitamin D (if continue to take Calcium) – umbrella analysis of meta-analyses Nov 2020
- Hip fractures not prevented by Vitamin D (800 IU daily or large quarterly or annual doses) – meta-analysis – Dec 2019
- Vitamin K (any amount and any kind) reduced bone fractures by 24 percent – meta-analysis – May 2019
- Vitamin D not help fractures and falls if not vitamin D deficient – meta-analysis Oct 2018
- Fractures not reduced by small amounts of vitamin D - meta-analysis Dec 2017
- Preventing Falls in Older Adults – Vitamin D combination is the best - JAMA Meta-analysis Nov 2017
- Hip fracture 58 percent more likely if low vitamin D – meta-analysis March 2017
- Fracture risk reduced somewhat by 800 IU of vitamin D and Calcium – meta-analysis Oct 2015
- Acute fracture patients – 70 percent were vitamin D deficient – meta-analysis Sept 2015
- Falls not prevented by vitamin D given every 3 months or less often – meta-analysis Jan 2015
- Vitamin D prevents falls – majority of meta-analyses conclude – meta-meta analysis Feb 2015
- Vitamin D and fractures – 24 meta-analyses and counting – Dec 2014
- Bone fractures reduced by a minimum of 800 IU vitamin D and Calcium – meta-meta-analysis March 2014
- Fractures reduced with any amount of vitamin D and some Calcium - Cochraine April 2014
- Fallers often had less than 20 ng of vitamin D – meta-analysis April 2014
- Hip fractures greatly reduced by sunshine, vitamin D, and vitamin K – meta-analysis Sept 2012
- Vitamin D may prevent falls and fractures without Calcium – an overview of 9 meta-analysis – Oct 2012
- Hip fractures reduced 30 percent with 800 IU of vitamin D – meta-analysis July 2012
- Vitamin D reduces falls – meta-analysis Oct 2011
- Active form of vitamin D (calcitriol) cut in half the fractures following organ transplant – meta-analysis Aug 2011
- 1000 IU minimum to decrease falls and fractures Swiss - 2009
- Meta-analysis of falls and 800+ IU of vitamin D found good results – June 2010
- 800 IU vitamin D reduces falls - Dec 2009
Vitamin D INCREASED falls – 7 reasons why the study was probably invalid– Jan 20168501 visitors, last modified 14 Jan, 2016, This page is in the following categories (# of items in each category)Attached files
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