Evidence map›Paper›PMID 25777546›Full record

Trial reportArthritis & rheumatology (Hoboken, N.J.)2015

Randomized, Double-Blind, Placebo-Controlled Trial of the Effect of Vitamin D3 on the Interferon Signature in Patients With Systemic Lupus Erythematosus.

Cynthia Aranow, Diane L Kamen, Maria Dall'Era, Elena M Massarotti, Meggan C Mackay, Fotios Koumpouras, Andreea Coca, W Winn Chatham, Megan E B Clowse, Lisa G Criscione-Schreiber and 6 more

3 registry-linked trialsOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Arthritis & rheumatology (Hoboken, N.J.), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 57 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
57citing papers in PubMed, 6 pooled it
11.0field-weighted citation impact, top 1% 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.

NCT00710021 phase2completednot on this map

Effect of Vitamin D3 on the IFN Alpha Signature in Patients With Systemic Lupus Erythematosus (ALE02)

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2008 to 2011Enrolled57ConditionsSystemic Lupus Erythematosus, SLE, LupusArmsVitamin D3, Vitamin D3 placebo
NCT05260255 nacompletednot on this mapstarted 2021, after this paper: background citation

The Effect of Vitamin D Supplementation on Disease Activity of Systemic Lupus Erythematosus Patients: A Randomized Clinical Trial in Rajavithi Hospital

TypeinterventionalSponsorDepartment of Medical Services Ministry of Public Health of ThailandRan2021 to 2022Enrolled100ConditionsVitamin D Deficiency, Hypocalcemia, Hyperparathyroidism, Systemic Lupus Erythematosus (Disorder)Armsvitamin D2 ( calciferol ), Placebo
NCT05430087 phase2completednot on this mapstarted 2020, after this paper: background citation

The Combination of Vitamin D and Curcumin Piperine Attenuates the Disease Activity and Pro-Inflammatory Cytokines Levels in Systemic Lupus Erythematosus Patients

TypeinterventionalSponsorSaiful Anwar HospitalRan2020 to 2022Enrolled45ConditionsSystemic Lupus ErythematosusArmsObserve the clinical outcome and inflammatory cytokines levels in patients with systemic lupus erythematosus (SLE) after being supplemented with Cholecalciferol (Vitamin D3) and Curcumin-Piperine.
3 · Its place in the literature

Who cites it

57 citing papers in PubMed, 6 syntheses or guidelines pooled it, 89 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Diet and Systemic Lupus Erythematosus (SLE): From Supplementation to Intervention.International journal of environmental research and public health · 2022
    Pooled it
  6. Pooled it
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Article
  13. Article
  14. Vitamin D in inflammatory rheumatic diseases: still a challenge.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2026
    Review
  15. Review
  16. The Role of Vitamin D in Autoimmune Diseases.International journal of molecular sciences · 2026
    Review
  17. Review
  18. Article
  19. Article
  20. Article
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

16 authors at 10 institutions in 1 country.

Cynthia AranowFeinstein Institute for Medical Research, Manhasset, New York.
Diane L KamenMedical University of South Carolina, Charleston.
Maria Dall'EraUniversity of California, San Francisco.
Elena M MassarottiBrigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
Meggan C MackayFeinstein Institute for Medical Research, Manhasset, New York.
Fotios KoumpourasWest Penn Hospital, Pittsburgh, Pennsylvania.
Andreea CocaUniversity of Rochester, Rochester, New York.
W Winn ChathamUniversity of Alabama at Birmingham.
Megan E B ClowseDuke University Medical Center, Durham, North Carolina.
Lisa G Criscione-SchreiberDuke University Medical Center, Durham, North Carolina.
Sherri CallahanNational Institute of Allergy and Infectious Diseases, NIH, Bethesda, Maryland.
Ellen A GoldmuntzNational Institute of Allergy and Infectious Diseases, NIH, Bethesda, Maryland.
Lynette Keyes-ElsteinRho Federal Systems, Chapel Hill, North Carolina.
Michaela OswaldFeinstein Institute for Medical Research, Manhasset, New York.
Peter K GregersenFeinstein Institute for Medical Research, Manhasset, New York.
Betty DiamondFeinstein Institute for Medical Research, Manhasset, New York.
Feinstein Institute for Medical Research · USDuke Medical Center · USNational Institute of Allergy and Infectious Diseases · USHarvard University · USMedical University of South Carolina · USRho (United States) · USUniversity of Alabama at Birmingham · USUniversity of California, San Francisco · USUniversity of Rochester · USWestern Pennsylvania Hospital · US

Funding

Transplantation GroupUM2AI117870 · NIAID · RHO FEDERAL SYSTEMS DIVISION, INC. · PI DAVID, GLORIA · 2015 to 2023
$208.1M
Supplement - Inflammatory Triggers in B Cell AutoimmunityU19AI056363 · NIAID · DUKE UNIVERSITY · PI ST. CLAIR, EUGENE WILLIAM · 2003 to 2017
$35.3M
SOUTH CAROLINA CLINICAL & TRANSLATIONAL RESEARCH INSTITUTE (SCTR)UL1RR029882 · NCRR · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI BRADY, KATHLEEN T. · 2009 to 2011
$10.1M
UAB Center for Clinical and Translational Science (CCTS) UL1UL1TR000165 · NCATS · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI KIMBERLY, ROBERT P. · 2012 to 2013
$9.6M
The Role of Vitamin D in Systemic Lupus ErythematosusK23AR052364 · NIAMS · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI KAMEN, DIANE L · 2007 to 2011
$647k
NCATS NIH HHS UL1 TR000165NCATS NIH HHS UL1-TR-00165NCRR NIH HHS RR-029882NCRR NIH HHS UL1 RR029882NIAID NIH HHS U19-AI-0563626NIAID NIH HHS U19 AI056363NIAID NIH HHS U19-AI-056363NIAID NIH HHS UM2 AI117870NIAMS NIH HHS K23 AR052364NIAMS NIH HHS K23-AR-052364
6 · The paper itself

Abstract

objectiveVitamin D modulates the immune response and blocks induction of an interferon (IFN) signature by systemic lupus erythematosus (SLE) sera. This study was undertaken to investigate the effects of vitamin D supplementation on the IFN signature in patients with SLE.

methodsSLE patients (n = 57) with stable, inactive disease, a serum 25-hydroxyvitamin D (25[OH]D) level ≤20 ng/ml, an elevated anti-double-stranded DNA antibody level, and an IFN signature (as determined by measuring the expression levels of 3 IFN response genes) were randomized into a 12-week double-blind, placebo-controlled trial of vitamin D3 at doses of 2,000 IU or 4,000 IU. An IFN signature response was defined as a 50% reduction in the expression of 1 of the 3 genes or a 25% reduction in the expression of 2 of the 3 genes. Disease activity, adverse events, and endocrine effects were assessed.

resultsBaseline characteristics of the patients in the 3 treatment groups (placebo, low-dose vitamin D3 , or high-dose vitamin D3 ) were similar. Repletion of 25(OH)D (i.e., levels ≥30 ng/ml) was not observed in any of the patients who were receiving placebo, while repletion was observed in 16 of 33 patients receiving vitamin D3 . The percentage of patients with an IFN signature response did not differ among the treatment groups. Moreover, there was no difference in the percentage of patients with an IFN signature response between those who remained vitamin D deficient and those who demonstrated repletion of vitamin D. Modular microarray analysis of a subset of patients (n = 40) did not reveal changes from baseline in any modules (including the IFN-inducible module) in any of the treatment groups, and no differences in expression were found between patients who demonstrated vitamin D repletion and patients who were persistently vitamin D deficient. Vitamin D3 was well tolerated, and there were no safety concerns.

conclusionVitamin D3 supplementation up to 4,000 IU daily was safe and well-tolerated but failed to diminish the IFN signature in vitamin D-deficient SLE patients. Higher 25(OH)D levels sustained for a longer duration may be required to affect immunologic outcomes.

Indexed as

Adaptor Proteins, Signal TransducingAdultAntibodies, Anti-IdiotypicAntigensCarrier ProteinsCholecalciferolCytoskeletal ProteinsDietary SupplementsDNADose-Response Relationship, DrugDouble-Blind MethodFemaleGene Expression RegulationHumansLupus Erythematosus, SystemicMale25-hydroxyvitamin DAdaptor Proteins, Signal TransducingAntibodies, Anti-IdiotypicAntigensCarrier ProteinsCholecalciferolCytoskeletal ProteinsDNAIFI44 protein, humanIFIT1 protein, humanMX1 protein, humanMyxovirus Resistance ProteinsRNA-Binding ProteinsVitamin D

Identifiers

PMID25777546
PMCPMC4732716
OpenAlexW2167518746

What OpenQuestion holds

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Registered trials

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.