Evidence map›Paper›PMID 27114973›Full record

ArticleNorth American journal of medical sciences2016

Safety of 50,000-100,000 Units of Vitamin D3/Week in Vitamin D-Deficient, Hypercholesterolemic Patients with Reversible Statin Intolerance.

Vybhav Jetty, Charles J Glueck, Ping Wang, Parth Shah, Marloe Prince, Kevin Lee, Michael Goldenberg, Ashwin Kumar

Abstract read
In one paragraph

Article in North American journal of medical sciences, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
2.5field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 28 citations in OpenAlex.

  1. Pooled it
  2. Association Between Vitamin D Supplementation and Statin-Associated Muscle Symptoms: A Systematic Review.High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension · 2022
    Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Vitamin D supplementations and mortality among patients with moderate/severe COVID-19: A meta-analysis of randomized controlled trials.Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences · 2024
    Review
  7. Statin-Associated Myopathy: Emphasis on Mechanisms and Targeted Therapy.International journal of molecular sciences · 2021
    Review
  8. Review
  9. Review
  10. Statin-Associated Muscle Disease: Advances in Diagnosis and Management.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2018
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 1 institution in 1 country.

Vybhav JettyCholesterol, Metabolism, and Thrombosis Center, Jewish Hospital of Cincinnati, Cincinnati, Ohio, USA.
Charles J GlueckCholesterol, Metabolism, and Thrombosis Center, Jewish Hospital of Cincinnati, Cincinnati, Ohio, USA.
Ping WangCholesterol, Metabolism, and Thrombosis Center, Jewish Hospital of Cincinnati, Cincinnati, Ohio, USA.
Parth ShahCholesterol, Metabolism, and Thrombosis Center, Jewish Hospital of Cincinnati, Cincinnati, Ohio, USA.
Marloe PrinceCholesterol, Metabolism, and Thrombosis Center, Jewish Hospital of Cincinnati, Cincinnati, Ohio, USA.
Kevin LeeCholesterol, Metabolism, and Thrombosis Center, Jewish Hospital of Cincinnati, Cincinnati, Ohio, USA.
Michael GoldenbergCholesterol, Metabolism, and Thrombosis Center, Jewish Hospital of Cincinnati, Cincinnati, Ohio, USA.
Ashwin KumarCholesterol, Metabolism, and Thrombosis Center, Jewish Hospital of Cincinnati, Cincinnati, Ohio, USA.
Jewish Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVitamin D deficiency (<32 ng/mL) is a reversible cause of statin-intolerance, usually requiring vitamin D3 (50,000-100,000 IU/week) to normalize serum D, allowing reinstitution of statins. Longitudinal safety assessment of serum vitamin D, calcium, and estimated glomerular filtration rate (eGFR) is important.

aimsProspectively assess the safety-efficacy of vitamin D3 therapy. MATERIALS AND

methodsIn 282 statin-intolerant hypercholesterolemic patients for 6 months and in 112 of the 282 patients for 12 months, with low-entry serum vitamin D (<32 ng/mL), we assessed safety-efficacy of vitamin D3 therapy (50,000-100,000 IU/week).

resultsOn mean (66,600 IU) and median (50,000 IU) of vitamin D3/week in 282 patients at 6 months, serum vitamin D rose from pretreatment (21-median) to 46 ng/mL (P < 0.0001), and became high (>100 ng/mL) but not toxic (>150 ng/mL) in 4 patients (1.4%). Median serum calcium was unchanged from entry (9.60 mg/dL) to 9.60 at 6 months (P = .36), with no trend of change (P = .16). Median eGFR was unchanged from entry (84 mL/min/1.73) to 83 at 6 months (P = .57), with no trend of change (P = .59). On vitamin D3 71,700 (mean) and 50,000 IU/week (median) at 12 months in 112 patients, serum vitamin D rose from pretreatment (21-median) to 51 ng/mL (P < 0.0001), and became high (>100 but <150 ng/mL) in 1 (0.9%) at 12 months. Median serum calcium was unchanged from entry (9.60 mg/dL) to 9.60 mg/dL and 9.60 mg/dL at 6 months and 12 months, respectively; P > 0.3. eGFR did not change from 79 mL/min/1.73 at entry to 74 mL/min/1.73 and 77 mL/min/1.73 at 6 months and 12 months, P > 0.3. There was no trend in the change in serum calcium (P > 0.5 for 6 months and 12 months), and no change of eGFR for 6 months and 12 months, P > 0.15.

conclusionsVitamin D3 therapy (50,000-100,000 IU/week) was safe and effective when given for 12 months to reverse statin intolerance in patients with vitamin D deficiency. Serum vitamin D rarely exceeded 100 ng/mL, never reached toxic levels, and there were no significant change in serum calcium or eGFR.

Indexed as

Deficiencyestimated glomerular filtration rate (eGFR)hypercalcemiahypervitaminosis Dmyalgiamyositisserum calciumsupplementationVitamin D

Identifiers

PMID27114973
PMCPMC4821095
OpenAlexW2302825899

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-SA
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.