Efficacy of vitamin D replacement therapy in restless legs syndrome: a randomized control trial
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Restless legs syndrome is a movement sleep disorder that may be linked to dopaminergic dysfunction and in which vitamin D may play a role. This 12-week randomized, placebo-controlled trial elucidated the efficacy of vitamin D supplements in decreasing restless legs syndrome symptom severity.
Thirty-five subjects with restless legs syndrome, diagnosed using the International Restless Legs Syndrome Study Group criteria, were enrolled. The subjects were randomized to orally receive either vitamin D (50,000 IU caplets) or a placebo. All medications were administered weekly using a direct observation technique. Clinical assessments, including those for restless legs syndrome severity, were conducted at baseline and the end of the study using the International Restless Legs Syndrome Study Group rating scale. The serum vitamin D levels and bone profiles were measured at baseline and every 4 weeks. The primary endpoint was the change in the restless legs syndrome severity score from baseline to week 12. There were 17 and 18 patients in the vitamin D and placebo groups, respectively.
The groups did not differ with respect to age, sex, restless legs syndrome severity, or vitamin D levels. Participants in the vitamin D group showed no significant change in the mean restless legs syndrome severity score compared with the placebo group.
The results suggest that vitamin D supplementation does not improve restless legs syndrome symptoms.
KeywordsRLS Primary Restless legs syndrome Scale Symptoms Vitamin D
We are grateful to the participants of the study. The authors would like to thank Dr. Ohoud Shakroon, Clinical Pharmacist, King Abdulaziz University Hospital, for her substantial assistance in providing the required medications. The authors greatly appreciate Drs. Mohamed Hamed, Khaled Aljammali, and Hanadi Sabbahi for their effort in collecting data. Finally, special thanks to Dr. Ghada Qadi for help with the preparation of the proposal and to Mrs. Walaa Abuzahra, Research Coordinator, Sleep Medicine and Research Center, for her time and effort in coordinating all procedures. The preliminary results of this study were presented at the Chest Annual Meeting 2017 (Wali SO, et al. Control ID 2729173. Presented at CHEST Annual Meeting, Oct 28–Nov 1, 2017, Toronto, ON, Canada).
Concept development: S.O.W. Study design: S.O.W. Data acquisition, supervision, data analysis, and interpretation: S.O.W., B.A., F.A. Manuscript preparation: S.O.W., B.A., F.A. Critical revision of the manuscript: S.O.W., S.R.P.-P. Prior to submission, all authors read and approved the final manuscript.
This project was funded by the Deanship of Scientific Research (DSR), King Abdulaziz University, Jeddah (grant no. G-1436-140-279). The authors acknowledge DSR with thanks for their technical and financial support. The funding source had no involvement in the study design, manuscript preparation, or decision to submit the article for publication.
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflicts of interest.
Ethics approval and consent for participation
The study was approved by the Human Institutional Ethics Committee of King Abdulaziz University Hospital (Approval No. HA-02-J-008). Informed consent was obtained from all participants.
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