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The Clinical Effects of Supplementation with Oral Strip and Soft Gelatin Capsule of Vitamin D in Deficient Patients: a Single-Blinded Clinical Trial

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Abstract

Vitamin D deficiency is common in different diseases. Differences in supplementary formulations can accelerate recovery from deficiency. Therefore, we aimed to evaluate the clinical effects of vitamin D supplementation with oral strip and soft gelatin capsule of vitamin D in deficient patients. This study is a single-blinded, randomized clinical trial on 60 patients with vitamin D deficiency during two months in Ahvaz. In the participants, serum levels of vitamin D were measured and recorded two times: at the initiation of the study and at the end. For the first group (control group), 50,000 units soft gelatin capsule of vitamin D (ergocalciferol) was administered to be taken orally weekly for eight continuous weeks and the second group, 2000 units oral strip of vitamin D, daily for 8 weeks. Patients who did not achieve normal serum levels were treated for an extra 4 weeks. At the end of the study, serum levels of vitamin D and calcium were measured, and data was analyzed by using the statistical software, SPSS. The results of the present study illustrated a notable difference in vitamin D serum levels after supplementation with oral strip or soft gelatin capsule in both arms of the study (p < 0.01), indicating a successful therapeutic approach. However, no significant differences were observed between two arms of the study, despite the higher amount of vitamin D consumed through soft gelatin capsule formulation (p >0.05). The results of this study demonstrated that supplementation with both formulations of oral strip or soft gelatin capsule can successfully treat vitamin D deficiency. Trial registration: IRCT20180408039235N1, Registration date: 2018-07-11

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Data availability

The datasets used and/or analyzed during the current study available from the corresponding author on reasonable request.

The raw SPSS file of this study before analysis is available upon your request.

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Funding

This study was financially supported by a grant from the Research and Technology Department of Jundishapur University of Medical Sciences, Ahvaz, Iran.

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Authors and Affiliations

  1. Department of Pharmacotherapy, School of Pharmacy, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran

    Reza Ganji

  2. Pharmacy, International Unit, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran

    Aryan Yousefi

  3. Department of Biostatistics and Epidemiology School of Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran

    Saeed Hesam

  4. Clinical Research Center, Department of Internal Medicine, Faculty of Medicine, North Khorasan University of Medical Sciences, Bojnurd, Iran

    Adeleh Sahebnasagh

  5. Clinical Pharmacy, Department of Surgical Medicine, Faculty of Medicine, North Khorasan University of Medical Sciences, Bojnourd, Iran

    Adeleh Sahebnasagh

  6. Imam Ali Hospital, Shahriar Street, Bojnurd, North Khorasan Province, Iran

    Adeleh Sahebnasagh

Authors
  1. Reza Ganji
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  2. Aryan Yousefi
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  3. Saeed Hesam
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  4. Adeleh Sahebnasagh
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Contributions

RG: the principal investigator and manager of the study, design and conduction the study

AY: head of treatment team, supervising on data records

SH: analysis and interpreting data

AS: Conception in design of the study, data drafting the manuscript and submission

Corresponding author

Correspondence to Adeleh Sahebnasagh.

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Ethics Approval

The ethical committee of Ahwaz University of Medical Sciences approved the study protocol (Ethics Code; IR.AJUMS.REC.1397.112).

Consent to Participate

All patients received verbal and printed information, and all provided written consent before entry into this study.

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Disclaimer

This grant providing funding to give medical agents, data analysis, and editorial assistance had no role in the study design and data collection.

Competing Interests

The authors declare no competing interests.

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Cite this article

Ganji, R., Yousefi, A., Hesam, S. et al. The Clinical Effects of Supplementation with Oral Strip and Soft Gelatin Capsule of Vitamin D in Deficient Patients: a Single-Blinded Clinical Trial. SN Compr. Clin. Med. 3, 1358–1362 (2021). https://doi.org/10.1007/s42399-021-00888-2

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  • DOI: https://doi.org/10.1007/s42399-021-00888-2

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