Randomised controlled trialcited by the Tayebat archiveabstract only checked A-SUP-21 standard review

High monthly vitamin D and falls

Monthly High-Dose Vitamin D Treatment for the Prevention of Functional Decline: A Randomized Clinical Trial.

Overview

Bischoff-Ferrari HA et al.. JAMA Intern Med 2016 · PMID 26747333 · DOI 10.1001/jamainternmed.2015.7148

More people fell with the higher monthly doses.

Does the study support the specific claim? Partly · Methodological quality: moderate

Original publication

Plain-language summary

Study explained simply
What did the researchers want to find out?

Function and falls.

How was the study done?

RCT.

How many people, animals or samples were studied?

200.

What was actually found?

More falls.

How large was the observed effect?

67% vs 48%.

What do the results mean in everyday life?

Avoid high boluses.

What are the study's limitations?

Small.

What does it say about Elawady's specific claim?

Partly supports.

Do the results apply to Germany and Europe?

Swiss.

What can explicitly not be concluded from this study?

Daily doses.

Scientific in-depth review

1. Full reference

Authors
Bischoff-Ferrari HA, Dawson-Hughes B, Orav EJ, Staehelin HB, Meyer OW, Theiler R, Dick W, Willett WC, Egli A
Journal
JAMA Intern Med
Year
2016
Identifier
PMID 26747333 DOI 10.1001/jamainternmed.2015.7148
Verification
verified – PubMed E-utilities efetch, 2026-10-25
Retracted
no
Corrections
none
Extent checked
abstract only
Conflicts of interest and funding

not stated in abstract

2. Research question

Does high-dose monthly vitamin D lower functional decline?

3. Study design and population

Study design
Randomised controlled trial – One-year double-blind RCT
Population

≥70 years with prior fall

Country

Switzerland

Period

2009–2011

Sample size

200

Inclusion and exclusion criteria

see abstract

4. Methods and endpoints

Exposure / intervention

60,000 IU D3 or 24,000 IU + calcifediol monthly

Comparator

24,000 IU monthly

Endpoints

Lower-extremity function; falls

Statistical methods

ITT

5. Actual results

Results

No difference in function (P=.26); falls 66.9% and 66.1% vs 47.9% (P=.048).

Absolute risks

not reported in abstract

Authors' conclusion

Higher monthly doses did not improve function and increased falls.

6. Strengths

  • RCT

7. Weaknesses

  • Small
  • Secondary outcome falls

8. Risk of bias

Orienting tool
RoB 2
Type of assessment
simplified assessment (abstract only)
Full formal assessment
no
Overall risk of bias
some concerns
Rationale

Small RCT; falls secondary.

9. Assessment of the statistical interpretation

See results.

10. Relevance to the specific claim

C-SUP-07.

11. Independent contrary findings

12. Transferability to Germany and Europe

High: biology and trial populations comparable to European adults.

13. Overall methodological judgement

Supports caution with high intermittent doses.

Multidimensional assessment
Multidimensional assessment
Authenticity of the sourceverified
Methodological qualitymoderate
Risk of biassome concerns
Precision of resultslow
Directnessdirect
Reproducibilitypartly replicated
Consistency with the overall evidenceconsistent
Regional transferabilityhigh
Adequacy of the interpretation (by the archive)essentially correct but incomplete

14. Open questions

15. Linked fact checks

Use by the Tayebat archive

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 high-dose monthly vitamin D lower functional decline?

B. What did the authors find?

No difference in function (P=.26); falls 66.9% and 66.1% vs 47.9% (P=.048).

C. What conclusions do the authors themselves draw?

Higher monthly doses did not improve function and increased falls.

D. What does the archive derive from it?

Supports dose-related harm.

E. Is this derivation scientifically justified?

Partly.

Adequacy of the interpretation (by the archive)
essentially correct but incomplete