Tier 1 — highest

Safety and tolerability of high-dose daily vitamin D3 supplementation in the vitamin D and type 2 diabetes (D2d) study-a randomized trial in persons with prediabetes

Karen C Johnson, Anastassios G Pittas, Karen L Margolis, Anne L Peters, Lawrence S Phillips, Ellen M Vickery, Jason Nelson, Patricia R Sheehan, David Reboussin, Saul Malozowski, Ranee Chatterjee, D2d research group
European journal of clinical nutrition 2022 76(8):1117-1124

Bibliography

PubMed
PMID 35140313
PubMed Central
PMC9352576
DOI
10.1038/s41430-022-01068-8
Trial registry
View on ClinicalTrials.gov Registered trial — results not yet published in a peer-reviewed journal.
Funding
Support is recorded from NIDDK NIH HHS. See the original publication for grant and material-support details.
Competing interests
The source discloses financial, employment, advisory or material-support relationships involving Pfizer, Roche. See the publication for the authors and nature of each relationship.

Study snapshot

DesignSafety analysis of the randomized D2d trial
ModelHuman participants
Sample2,423 adults with prediabetes and overweight or obesity
InterventionVitamin D3 4,000 IU/day or placebo
DurationApproximately 3 years of safety follow-up
EndpointsAdverse and serious adverse events; Hypercalcemia; Hypercalciuria; Kidney stones

What the study showed, in plain terms

This publication examines adverse and serious adverse events, hypercalcemia, hypercalciuria, kidney stones. Study population or evidence base: 2,423 adults with prediabetes and overweight or obesity. Intervention or exposure: Vitamin D3 4,000 IU/day or placebo.

Key findings

With trial monitoring, 4,000 IU/day was generally well tolerated and did not significantly increase the prespecified calcium-related, renal or serious adverse outcomes.

What this study can and cannot tell us

Trial screening and safety monitoring matter. These findings do not establish unrestricted safety of higher daily doses or of the same dose in every clinical population.

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