Randomised controlled trialcited by the Tayebat archiveabstract only checked A-SUP-20 standard review

Yearly vitamin D mega-dose

Annual high-dose oral vitamin D and falls and fractures in older women: a randomized controlled trial.

Overview

Sanders KM et al.. JAMA 2010 · PMID 20460620 · DOI 10.1001/jama.2010.594

More falls and fractures with 500,000 IU once a year.

Does the study support the specific claim? Yes · Methodological quality: high

Study explained simply

What did the researchers want to find out?: Falls prevention.
How was the study done?: RCT.
How many people, animals or samples were studied?: 2,256 women.
What was actually found?: More falls and fractures.
How large was the observed effect?: RR 1.15; 1.26.
What do the results mean in everyday life?: Avoid mega-doses.
What are the study's limitations?: Regimen-specific.
What does it say about Elawady's specific claim?: Supports for this regimen.
Do the results apply to Germany and Europe?: Applicable.
What can explicitly not be concluded from this study?: Daily doses.

Authors: Sanders KM, Stuart AL, Williamson EJ, Simpson JA, Kotowicz MA, Young D, Nicholson GC
Journal: JAMA
Year: 2010
Identifier: PMID 20460620 DOI 10.1001/jama.2010.594
Verification: verified – PubMed E-utilities efetch, 2026-10-25
Retracted: no
Corrections: PubMed lists: ErratumIn (JAMA. 2010 Jun 16;303(23):2357)
Extent checked: abstract only
Conflicts of interest and funding: not stated in abstract

Does annual 500,000 IU oral cholecalciferol reduce falls and fractures?

Study design: Randomised controlled trial – Double-blind placebo-controlled RCT
Population: Community-dwelling women ≥70 at high fracture risk
Country: Australia
Period: 2003–2008; 3–5 years
Sample size: 2,256
Inclusion and exclusion criteria: see abstract

Results: Falls RR 1.15 (1.02–1.30); fractures RR 1.26 (1.00–1.59); 4.9 vs 3.9 fractures per 100 person-years; falls RR 1.31 in first 3 months.
Absolute risks: 4.9 vs 3.9 fractures per 100 person-years
Authors' conclusion: Annual high-dose cholecalciferol increased falls and fractures.

See results.

VITAL daily 2,000 IU: no excess adverse events.

High: biology and trial populations comparable to European adults.

Clear harm of mega-bolus.

Multidimensional assessment
Multidimensional assessment
Authenticity of the source	verified
Methodological quality	high
Risk of bias	low
Precision of results	moderate
Directness	direct
Reproducibility	partly replicated
Consistency with the overall evidence	consistent
Regional transferability	high
Adequacy of the interpretation (by the archive)	essentially correct but incomplete

Note: according to the archive, the studies were compiled by the archive operators. Whether Dr. Elawady himself cited this study is not established.

What the archive says about the study: Listed in the archive bibliography of the oral-supplements rule without its own interpretation; used implicitly to support the rule summary that supplements 'failed or caused harm' in large trials.
A. What was actually studied?: Does annual 500,000 IU oral cholecalciferol reduce falls and fractures?
B. What did the authors find?: Falls RR 1.15 (1.02–1.30); fractures RR 1.26 (1.00–1.59); 4.9 vs 3.9 fractures per 100 person-years; falls RR 1.31 in first 3 months.
C. What conclusions do the authors themselves draw?: Annual high-dose cholecalciferol increased falls and fractures.
D. What does the archive derive from it?: Supports 'more hip fractures'/falls.
E. Is this derivation scientifically justified?: Yes for mega-bolus; not for daily dosing.
Adequacy of the interpretation (by the archive): essentially correct but incomplete