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The effect of a single dose of vitamin D on glycemic status and C-reactive protein levels in type 2 diabetic patients with ischemic heart disease: a randomized clinical trial

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Abstract

Aims

To assess whether a single parental dose of 25-hydroxy vitamin D [25(OH)Vit D] could improve glucose control and inflammation in type 2 diabetic patients (T2D) with ischemic heart disease (IHD).

Methods

A randomized, placebo-controlled, double-blind trial was performed on 95 patients (47—placebo and 48—vitamin D groups). Participants were randomized using a randomization table to a single dose of either vitamin D (300,000 IU, IM) or a matching placebo. Fasting blood sugar (FBS), glycosylated hemoglobin (HbA1c), 25(OH)Vit D and high-sensitivity C-reactive protein (hs-CRP) were measured at baseline and at 8 weeks.

Results

No significant differences in baseline values were noted between groups, except in HbA1c, which was lower in the placebo group. In the supplemented group, the level of serum 25(OH)Vit D increased (29.6 ± 20.8 vs. 44.5 ± 19.2 ng/mL) and those of FBS and HbA1c decreased significantly [186.5 ± 64.1 vs. 165.1 ± 58.5 mg/dL and 8.2 ± 2.0 % (66.3 ± 21.8 mmol/mol) vs. 7.7 ± 1.8 % (61.7 ± 20.0 mmol/mol), respectively] (all p < 0.05), and no changes, however, were observed in the placebo group. We also compared change of marginal means of outcome variables (HbA1c, FBS, 25(OH)Vit D and hs-CRP) from baseline between the vitamin D versus placebo group, using ANCOVA, adjusted for the baseline of each variable itself, season at study entry, age and body mass index. During trial, only HbA1c level decreased significantly [0.48 % (standard error: 0.17), p = 0.04]. No any adverse effect was seen.

Conclusions

A single parenteral dose of vitamin D in T2D patients with IHD improved glycemic control, but not inflammatory status.

Clinical trial registry

Australian New Zealand Clinical Trial Registry.

Clinical trial number

ACTRN12614000529640.

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Acknowledgments

This study was funded by the Research Institute for Endocrine Sciences of Shahid Beheshti University of Medical Sciences (Grant No. 551). The authors wish to acknowledge Ms Niloufar Shiva for critical editing of English grammar and syntax of the manuscript. This manuscript is the result of a residency thesis in the clinical pharmacology of Dr Elnaz Shaseb in Shahid Beheshti University of Medical Sciences.

Author information

Authors and Affiliations

  1. Clinical Pharmacy Department, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic of Iran

    E. Shaseb & M. Abbasinazari

  2. Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, P.O. Box: 19395-4763, Tehran, Islamic Republic of Iran

    E. Shaseb, M. Tohidi, D. Khalili & F. Hadaegh

  3. Pharmaceutical Sciences Branch, Islamic Azad University, Tehran, Islamic Republic of Iran

    H. Omrani

  4. Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Islamic Republic of Iran

    A. H. Talasaz

Authors
  1. E. Shaseb
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  2. M. Tohidi
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Corresponding author

Correspondence to M. Tohidi.

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Conflict of interest

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Ethical standard

Ethics committee of Shahid Beheshti University of Medical Science (8ECRIES- 2013) approved this study.

Human and animal rights

All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008 (5).

Informed consent

Informed consent was obtained from all patients for being included in the study.

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Shaseb, E., Tohidi, M., Abbasinazari, M. et al. The effect of a single dose of vitamin D on glycemic status and C-reactive protein levels in type 2 diabetic patients with ischemic heart disease: a randomized clinical trial. Acta Diabetol 53, 575–582 (2016). https://doi.org/10.1007/s00592-016-0843-3

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  • DOI: https://doi.org/10.1007/s00592-016-0843-3

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