Vitamin D INCREASED falls – 7 reasons why the study was probably invalid– Jan 2016

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

1. Which people were taking drugs for fall prevention
2. Which people were taking high blood pressure medication – which increases falls
3. The cause of the falls – dizziness, poor sight, poor muscle strength, slow muscle response
4. Number of previous falls (study ignored if person had 1 fall or 10 falls in the previous year)
5. All falls were considered to be the same.
   Whereas some falls make a person more likely to have further falls
6. 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
7. METs/month were not reported for the secondary analysis.
   It is likely that less active ==> less likely to fall

In addition: Strangely

1. 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
2. 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.
3. The study clipped the fall rate – treating number of falls > 5 as =5.
   This truncation greatly distorts the data
4. 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

• 254 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

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See also GrassrootsHealth Controversy- Jan 2016

The following table is extracted from the above image, so that text can be found and translated

1. 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.

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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 VitaminDWiki

The editorial ignores many published meta-analyses - which can be found in VitaminDWiki

The Meta-analysis of CANCER and Vitamin D

The Meta-analysis of Breast Cancer and Vitamin D

The Meta-analysis of Colon Cancer and Vitamin D

The Meta-analysis of Falls/Fractures