The effect of vitamin D supplementation on tobacco-related disorders in individuals with a tobacco use disorder: a randomized clinical trial

Abstract

Vitamin D deficiency in cigarette smokers (CS) might associate with several complications, including metabolic deficits, depression and anxiety. This study evaluated the effects of vitamin D on mental health symptoms, nicotine misuse, and biomarkers of metabolic diseases in individuals with a tobacco use disorder. A randomized, double-blind, placebo-controlled trial was conducted with 60 CS subjects receiving either 50,000 IU vitamin D supplements (n = 30) or placebo (n = 30) every 2 weeks for 24-weeks. Nicotine misuse, mental health scale, and metabolic parameters were measured before and after the intervention in the CS subjects. Compared with the placebo-group, after the 24-weeks intervention, serum 25 (OH) vitamin D levels increased in the intervention group (β 2.96; 95% CI, 0.91, 5.01; P = 0.006). In addition, vitamin D supplementation significantly improved Beck Depression Inventory (BDI) (β −2.06; 95% CI, −3.84, −0.28; P = 0.02). In addition, vitamin D administration significantly decreased fasting plasma glucose (FPG) (β −4.56; 95% CI, −8.94, −0.19; P = 0.04), insulin (β −0.50; 95% CI, −0.88, −0.13; P = 0.009), and homeostasis model of assessment-estimated insulin resistance (HOMA-IR) levels (β −0.21; 95% CI, −0.33, −0.08; P = 0.001). Furthermore, vitamin D resulted in a significant elevation in total antioxidant capacity (TAC) (β 81.20; 95% CI, 18.30, 144.11; P = 0.01), and plasma glutathione (GSH) levels (β 73.05; 95% CI, 18.56, 127.54; P = 0.01), compared with the placebo-group. Administration of vitamin D for 24-weeks to CS subjects had beneficial effects on symptoms of depression and several metabolic biomarkers. While this preliminary study suggests that vitamin D might have beneficial effects, its clinical efficacy in individuals with a tobacco use disorder should be further validated in future clinical trials.

Keywords:

• Vitamin D supplementation
• cigarette smokers
• nicotine misuse
• mental health
• metabolic biomarkers

Acknowledgments

This study was the doctoral thesis on General Medicine (Soheil Bagheri). It has been registered with the IRCT20170420033551N7 registration code in the Iranian Center for Clinical Trials, and was supported by a grant from the Vice-chancellor for Research, KAUMS, Iran (98025). We are thankful of all subjects who participated in this project.

Disclosure statement

The authors declare that there are no conflicts of interest.

Authors’ contributions

Amir Ghaderi, Azam Mesdaghinia, and Hamid Reza Banafshe designed the study, provided oversight to the implementation, contributed to the interpretation and writing with input from Fatemeh Sadat Ghoreishi. Amir Ghaderi and Ahmad Reza Saghazade conducted the primary analysis with guidance from Samira Abbaszadeh-Mashkani and Azam Mesdaghinia. Soheil Bagheri, Ahmad Reza Saghazade, Samira Abbaszadeh-Mashkani, Fatemeh Sadat Ghoreishi, Hamid Reza Banafshe, Azam Mesdaghinia, and Amir Ghaderi contributed in data collection and manuscript drafting.

Ethics approval and consent to participate

At the beginning of the questionnaire distribution session, the purpose of the study was explained for the participants and they were assured about the anonymity and confidentiality of their responses. All participants gave their signed written informed consent letters. The study protocol was approved by the Ethics Committee of Kashan University of Medical Sciences “approval no. IR.KAUMS.MEDNT.REC.1398.026”. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki declaration and its later amendments.

Availability of data and materials

The datasets generated and/or analyzed during the current study are not publicly available because the intellectual property is owned by the funding body. They may be available from the corresponding author on reasonable request containing the approval from the associated funding body.

Additional information

Funding

The research grant provided by Research Deputy of Kashan University of Medical Sciences (KAUMS/98025).