The Effect of Vitamin D Supplementation on Inflammatory and Hemostatic Markers and Disease Activity in Patients with Systemic Lupus Erythematosus: A Randomized Placebo-controlled Trial. The Journal of Rheumatology, 2013;40:265–72; doi:10.3899/jrheum.111594. Anna Abou-Raya, Suzan Abou-Raya, and Madihah Helmii.
The Journal hereby retracts this article.
It was brought to the attention of The Journal that there were some significant problems with the above-named paper. This resulted in an internal investigation and then subsequent submission of our concerns to the authors and the authors’ university. The Faculty of Medicine of the University of Alexandria struck an Investigation Committee and submitted a copy of its report to The Journal. The conclusions of the committee were that there were errors in the article but that they were all unintentional and based on the evidence. The committee concluded and confirmed that all authors exercised appropriate responsibility and integrity in ensuring the validity of the data. Following that assessment, The Journal reinvestigated issues raised and concluded that some of the issues initially raised remain major concerns and that the above-named paper should be retracted.
A summary of the concerns:
The baseline characteristics were almost identical between the treatment and the placebo groups despite the statement that the patients were randomized. Our re-assessment following the response of the authors and the Investigation Committee is that the probability of all these values being identical at baseline is too low to be by chance alone.
The number of patients enrolled in the study was 267 according to the paper, but differed from the number in ClinicalTrials.gov, which was 248. The explanation was that the original plan was to enroll 248 but that 267 were enrolled. It is not clear how many patients were actually in the trial.
The registration of the trial with ClinicalTrials.gov took place after the study was completed.
Multiple statistical errors were noted throughout the paper. The Investigation Committee concluded that they were inadvertent. Our re-review finds that the number of errors must lead to a question of the veracity of the data.
