Evidence map›Paper›PMID 26351776›Full record

Trial reportThe American journal of the medical sciences2015

A Pilot Study to Determine if Vitamin D Repletion Improves Endothelial Function in Lupus Patients.

Diane L Kamen, Jim C Oates

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in The American journal of the medical sciences, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
3.3field-weighted citation impact, top 8% 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, 29 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Vitamin D and connective tissue diseases.Inflammation research : official journal of the European Histamine Research Society ... [et al.] · 2020
    Review
  5. Article
  6. Article
  7. Article
  8. Update on cardiovascular disease in lupus.Current opinion in rheumatology · 2016
    Review
  9. Article
  10. 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

2 authors at 2 institutions in 1 country.

Diane L KamenDivision of Rheumatology and Immunology (DLK, JO), Department of Medicine, Medical University of South Carolina, Charleston, South Carolina; and Rheumatology Section (JO), Medical Service, Ralph H. Johnson VA Medical Center, Charleston, South Carolina.
Jim C Oates
Medical University of South Carolina · USRalph H. Johnson VA Medical Center · US

Funding

ZINC AND COPPER METABOLISM IN COLLAGEN DISORDERSM01RR001070 · NCRR · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI REVES, JOSEPH G · 1985 to 2009
$16.3M
SOUTH CAROLINA CLINICAL & TRANSLATIONAL RESEARCH INSTITUTE (SCTR)UL1RR029882 · NCRR · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI BRADY, KATHLEEN T. · 2009 to 2011
$10.1M
Patient Resource CoreP60AR062755 · NIAMS · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI GILKESON, GARY S · 2012 to 2016
$5.8M
The Role of Vitamin D in Systemic Lupus ErythematosusK23AR052364 · NIAMS · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI KAMEN, DIANE L · 2007 to 2011
$647k
NCRR NIH HHS M01 RR001070NCRR NIH HHS M01RR001070NCRR NIH HHS UL1 RR029882NIAMS NIH HHS K23 AR052364NIAMS NIH HHS P60 AR062755
6 · The paper itself

Abstract

backgroundThe endothelium is important not only in regulating vascular tone but also in modulating inflammation. Patients with systemic lupus erythematosus (SLE) have deficits in these endothelial functions. Vitamin D is a nuclear hormone that regulates vascular endothelial nitric oxide synthase activity and expression. Many SLE patients have insufficient levels of vitamin D. The effect of this hormone on vascular endothelial function in SLE patients is not known. This study was designed to determine the effect size of repleting vitamin D levels on endothelial function in patients with SLE and vitamin D deficiency.

methodsSLE patients with 25(OH) vitamin D (25(OH)D) levels <20 ng/mL were randomized to oral vitamin D3 (D3) doses that did or did not raise 25(OH)D levels to ≥32 ng/mL. Endothelial function was measured with flow-mediated dilation (FMD) before and after 16 weeks of vitamin D3 supplementation.

resultsHalf of those who achieved 25(OH)D levels of ≥32 ng/mL experienced increases in FMD, whereas none of those with continued low 25(OH)D levels did. Those with increases in FMD had significantly higher final 25(OH)D levels. Using the effect size from this study, future studies designed to test the effect of repleting 25(OH)D on FMD in vitamin D-deficient SLE patients will require 35 patients in each group.

conclusionsThese results suggest a potential role for vitamin D in SLE-related endothelial dysfunction and that an adaptive, multi-arm, treat-to-target, serum-level trial design may increase the efficiency and likelihood of success of such a study.

Indexed as

Administration, OralAdultCholecalciferolDietary SupplementsEndotheliumFemaleHumansInflammationLupus Erythematosus, SystemicMaleMiddle AgedPilot ProjectsVascular DiseasesVitamin D DeficiencyCholecalciferol

Identifiers

PMID26351776
PMCPMC4589474
OpenAlexW2250245177

What OpenQuestion holds

Textmetadata
LicenceTDM
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.