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other·endocrinology, neurology, clinical trial, vitamins, micronutrients·PMC10361572

Efficacy and safety of high-dose intramuscular vitamin D 2 injection in type 2 diabetes mellitus with distal symmetric polyneuropathy combined with vitamin D insufficiency: study protocol for a multicenter, randomized, double-blinded, and placebo-controlled trial

Frontiers in Endocrinology · 15 authors, 9 centres

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TL;DR

This paper outlines the protocol for a randomized, placebo-controlled trial investigating whether monthly intramuscular injections of high-dose vitamin D2 can improve neuropathy in patients with type 2 diabetes, distal symmetric polyneuropathy, and vitamin D insufficiency. The primary outcome will be the change in the Michigan Neuropathy Screening Instrument score after 3 months.

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This is a study protocol for a multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of high-dose intramuscular vitamin D2 (HDVD) in patients with type 2 diabetes mellitus (T2DM) and distal symmetric polyneuropathy (DSPN) who also have vitamin D insufficiency. Eligible participants will be randomly assigned to receive monthly injections of HDVD or a placebo for 3 months. The primary outcome is the change in the mean Michigan Neuropathy Screening Instrument (MNSI) score from baseline to 3 months post-intervention. Safety will be monitored through assessments of liver and renal function, electrolytes, and reporting of adverse events. The discussion notes that while observational studies link vitamin D deficiency to DSPN, low-dose supplementation has shown limited efficacy. This trial aims to provide the first evidence from a randomized controlled trial in China on whether HDVD can improve neuropathy and correct deficiency quickly with high compliance.

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other

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endocrinology

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ORIGINAL PAPER

PMC10361572

Efficacy and safety of high-dose intramuscular vitamin D 2 injection in type 2 diabetes mellitus with distal symmetric polyneuropathy combined with vitamin D insufficiency: study protocol for a multicenter, randomized, double-blinded, and placebo-controlled trial

Frontiers in Endocrinology

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ABSTRACT

Background Distal symmetric polyneuropathy (DSPN) is the most common chronic complication of type 2 diabetes mellitus (T2DM). DSPN may lead to more serious complications, such as diabetic foot ulcer, amputation, and reduced life expectancy. Observational studies have suggested that vitamin D deficiency may be associated with the development of DSPN in T2DM. However, interventional studies have found that low-dose vitamin D supplementation does not significantly improve neuropathy in DSPN. This study aims to evaluate the efficacy and safety of intramuscular injection of high-dose vitamin D (HDVD) in T2DM with DSPN combined with vitamin D insufficiency. Methods and analysis We will conduct a multicenter, randomized, double-blinded, and placebo-controlled trial in four large hospitals. All eligible participants will be randomly assigned to either the vitamin D 2 supplement or placebo control group and injected intramuscularly monthly for 3 months. Additionally, anthropometric measurements and clinical data will be collected at baseline and 3 months. Adverse events will be collected at 1, 2, and 3 months. The primary outcome measure is the change in the mean Michigan Neuropathy Screening Instrument (MNSI) score at baseline and 3 months post-intervention. We will use the gold-standard liquid chromatography-tandem mass spectrometry method to distinguish between 25(OH)D 2 and 25(OH)D 3 levels. The MNSN score before the intervention will be used as a covariate to compare the changes between both groups before and after the intervention, and the analysis of covariance will be used to analyze the change in the MNSI score after HDVD supplementation. Discussion Glycemic control alone does not prevent the progression of DSPN in T2DM. Some studies have suggested that vitamin D may improve DSPN; however, the exact dose, method, and duration of vitamin D supplementation are unknown. Additionally, neuropathy repair requires HDVD supplementation to sustain adequate vitamin D levels. This once-a-month intramuscular method avoids daily medication; therefore, compliance is high. This study will be the first randomized controlled trial in China to analyze the efficacy and safety of HDVD supplementation for patients with T2DM and DSPN and will provide new ideas for pharmacological research and clinical treatment of diabetic neuropathy. Clinical trial registration https://www.chictr.org.cn/ , identifier ChiCTR2200062266.

CITATION EXPORT

Tao Chen, Xiaoyan Xing, Lihua Huang et al.. Efficacy and safety of high-dose intramuscular vitamin D2 injection in type 2 diabetes mellitus with distal symmetric polyneuropathy combined with vitamin D insufficiency: study protocol for a multicenter, randomized, double-blinded, and placebo-controlled trial. Frontiers in Endocrinology. (2023). https://doi.org/10.3389/fendo.2023.1202917

AUTHORS

15 · 9 CENTRES

Tao Chen, Xiaoyan Xing, Lihua Huang, Mei Tu, Xiaoli Lai, Shidi Wen, Jin Cai, Shenglong Lin, Youping Zheng, Yuehui Lin, Lijuan Xu, Yuwen Qiu, Lumin Qiu, Yuebo Xu, Peiwen Wu

1 Department of Endocrinology, Clinical Research Center for Metabolic Diseases of Fujian Province, the First Affiliated Hospital, Fujian Medical University, Fuzhou, China
2 Department of Endocrinology and Metabolism, Longyan First Affiliated Hospital of Fujian Medical University, Longyan, China
3 Department of Endocrinology and Metabolism, China-Japan Friendship Hospital, Beijing, China
4 Department of Tumor Radiotherapy, Longyan First Affiliated Hospital of Fujian Medical University, Longyan, China
5 Department of Severe Liver Disease, Mengchao Hepatobiliary Hospital of Fujian Medical University, Fuzhou, China
6 Department of Ultrasound, Longyan First Affiliated Hospital of Fujian Medical University, Longyan, China
7 Department of Endocrinology and Metabolism, Longyan Traditional Chinese Medicine Affiliated Hospital of Fujian University of Traditional Chinese Medicine, Longyan, China
8 Department of Endocrinology and Metabolism, Longyan Shanghang County Hospital, Longyan, China
9 Department of Diabetes, Longyan Boai Hospital, Longyan, China