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J Nephropathol. 2024;13(3): e17163.
doi: 10.34172/jnp.2022.17163

Scopus ID: 85195313796
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Original Article

The effects of calcitriol on microalbuminuria in patients with type 2 diabetes mellitus; a double-blind randomized clinical trial

Maryam Askari 1 ORCID logo, Akram Ghadiri-Anari 2 ORCID logo, Asma Jaafarinia 1 ORCID logo, Shadab Kharazmi 3 ORCID logo, Roya Hemayati 4* ORCID logo

1 Genetic and Environmental Adventures Research Center, School of Abarkouh Paramedicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
2 Department of Internal Medicine, Diabetes Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
3 Faculty of Psychology and Educational Sciences, Yazd University, Yazd, Iran
4 Department of Internal Medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
*Corresponding Author: Roya Hemayati, Email: hemayatiroya@gmail.com, Email: drhemayati@ssu.ac.ir

Abstract

Introduction: Diabetes mellitus (DM) is a metabolic disorder appearing as a main public health problem nowadays.

Objectives: This study aimed to evaluate the effect of calcitriol on microalbuminuria in patients with type 2 DM (T2DM).

Patients and Methods: This double-blind randomized clinical trial was performed on 38 patients with T2DM who had micro- albuminuria. These patients were randomly classified into two groups of treatment and control. The treatment group received calcitriol 0.25 μg daily since the control group received a placebo. Duration of treatment was three months. In baseline, serum creatinine (Cr), fasting blood sugar (FBS), glycated hemoglobin (HbA1c), cholesterol (Chol), triglyceride (TG), low-density lipoprotein (LDL-c), high-density lipoprotein (HDL-c), and micro-albuminuria were measured. Patients were followed up for three months. P<0.05 was set as a significant level.

Results: In baseline, two groups did not differ significantly in terms of serum Cr, FBS, HbA1c, Chol, TG, HDL-c, LDL-c, and micro-albuminuria (P> 0.05). After the intervention, there was no significant difference between the two groups regarding the median of serum Cr, FBS, HbA1c, Chol, TG, LDL-c, HDL-c, and microalbuminuria. The median of microalbuminuria in the treatment and control groups was decreased at 46 mg/g and 11 mg/g, respectively. The difference in median of micro-albuminuria was not statically significant between the two groups; however, a significant difference was detected in the treatment group before and after the intervention (P=0.03).

Conclusion: Administration of calcitriol could reduce micro-albuminuria after three months. Therefore, the addition of calcitriol to angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) in patients with T2DM and micro- albuminuria may have a beneficial effect on reducing their proteinuria.

Trial Registration: The trial protocol was approved by the Iranian Registry of Clinical Trials (identifier: IRCT2016091429812N; https://en.irct.ir/trial/23865, ethical code; IR.SSU.Rec.65415).


Implication for health policy/practice/research/medical education:

This trial was conducted on 32 patients with type 2 diabetes mellitus who had microalbuminuria. The difference in median of microalbuminuria was not statically significant between the two groups; however, a significant difference was detected in the treatment group before and after the intervention. Administration of calcitriol could reduce microalbuminuria after three months.

Please cite this paper as: Askari M, Ghadiri-Anari A, Jaafarinia A, Kharazmi S, Hemayati R. The effects of calcitriol on microalbuminuria in patients with type 2 diabetes mellitus; a double-blind randomized clinical trial. J Nephropathol. 2024;13(3):e17163. DOI: 10.34172/ jnp.2022.17163.

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Submitted: 30 Dec 2020
Accepted: 06 Sep 2021
ePublished: 20 Sep 2021
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