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Articles

Effect of Cholecalciferol Supplementation on Treatment Response and IL-10 Level in Vitamin D Deficient Parthenium Dermatitis Patients: A Randomized Double-Blind Placebo-Controlled Trial

, MD, DNB, DMORCID Icon, , MD, DNB, DMORCID Icon, , MD, DNBORCID Icon & , MD, DMORCID Icon
Pages 415-428 | Published online: 24 May 2019
 

Abstract

Allergic contact dermatitis following exposure to Parthenium is a chronic disease associated with frequent relapses and significant disturbance in the quality of life. The affected patients have lower circulating levels and decreased expression of IL-10. Hence, measures to increase its level may enhance the therapeutic outcome. The clinical trial was undertaken to evaluate the effect of cholecalciferol supplementation on treatment response and IL-10 level in Parthenium dermatitis patients with vitamin D deficiency. A total of 72 patients were recruited and randomized to receive either cholecalciferol tablet 60,000 IU per week or matching placebo for 8 weeks with standard background treatment. Eczema Area Severity Index (EASI) and Dermatology Life Quality Index (DLQI) were assessed at baseline, 4 weeks, and 8 weeks while IL-10 and serum 25-hydroxyvitamin D levels were measured at baseline and 8 weeks. Levels of 25-hydroxyvitamin D and IL-10 showed a significant rise in both placebo and vitamin D groups following the intervention. The relatively higher increase in IL-10 level observed in the vitamin D group was statistically insignificant compared to placebo group. Significant reduction in EASI, as well as DLQI scores, was noted after 1 and 2 months, but the reduction in these scales was not significantly different between the groups. Cholecalciferol supplementation for 2 months did not reduce the disease severity in clinically diagnosed Parthenium dermatitis patients. However, treatment initiation significantly improved plasma IL-10 levels after 2 months in both placebo and cholecalciferol groups.

Acknowledgments

The authors thank all the participants of the trial for their indispensable contribution. We thank JIPMER administration for their support in conducting this study and for the intramural research grant. The authors acknowledge Mr. Rajan, Ms. Padmapriya (Department of Pharmacology), Mr. Venkatraman, and Mrs. Saraswathi (Department of Endocrinology) for their help in laboratory work.

Declaration of interest

The authors declare no conflicts of interest. The authors alone are responsible for the content and writing of the article.

About the authors

Dr. Alphienes Stanley Xavier, MD (Pharmacology), DNB (Pharmacology), DM (Clinical Pharmacology), Assistant Professor, Department of Pharmacology, Sri Ramachandra Institute of Higher Education and Research (SRIHER), Porur, Chennai-600116, India; Research Interest – Drug Interactions, Precision Medicine, Clinical Pharmacodynamics, Therapeutic Drug Management.

Dr. Sandhiya Selvarajan, MD (Pharmacology), DNB (Pharmacology), DM (Clinical Pharmacology), Associate Professor, Department of Clinical Pharmacology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry-605006, India; Research Interest – Drug Regulations, Bioethics, Vitamin D, Clinical Pharmacokinetics.

Dr. Laxmisha Chandrasekar, MD (Dermatology and Venereology), DNB (Dermatology, Venereology, and Leprosy), Additional Professor, Department of Dermatology and Sexually Transmitted Diseases, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry-605006, India; Research Interest – Pigmentary Disorders, Pemphigus, Immuno-Dermatology, Dermatological Imaging.

Dr. Sadishkumar Kamalanathan, MD (General Medicine), DM (Endocrinology), Additional Professor, Department of Endocrinology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry-605006, India; Research Interest – Bone Health, Vitamin D, Insulin Resistance, Thyroid Disorders.

Additional information

Funding

Investigator-initiated clinical trial financially supported by an institutional intramural grant (JIPMER, Puducherry, India).

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