Long-Term Bioavailability of Single Doses of Intramuscular Vitamin D2

Xu, Feng; Dai, Dexing; Sun, Ruoman; Liu, Zhenming; Lin, Xiaolin; Li, Lusha; Xing, Xiaoping; Li, Chunlin; Xie, Zhongjian

doi:10.4158/ep-2020-0124

Cited by 3 publications

(7 citation statements)

References 40 publications

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“…High levels of serum iPTH are often observed in patients with insufficient vitamin D, while vitamin D supplementation can decrease serum iPTH concentrations [ 38 ]. In contrast to previous reports that vitamin D at doses of 50,000 IU orally, 200,000 IU or above intramuscularly reduced serum levels of iPTH [ 17 , 27 ], we observed no significant change in serum levels of iPTH in very elderly Chinese patients after high-dose intramuscular vitamin D2 intervention. This could be explained at least in part by the lower baseline iPTH serum levels observed in our present study [ 22 ].…”

Section: Discussioncontrasting

confidence: 99%

“…Xu and colleagues found that, after a single high dose of intramuscular vitamin D2, the level of 25(OH)D2 increased slowly and plateaued for 12 weeks [ 27 ]. In general, a single high-dose of oral vitamin D2 is initially more effective than the equivalent intramuscular one in increasing serum 25(OH)D, while the latter can produce a slower but more long-lasting increase [ 22 , 33 ].…”

Section: Discussionmentioning

confidence: 99%

“…A single intramuscular dose of 300,000 IU vitamin D2 was shown not to effectively correct vitamin D deficiency [ 26 , 33 ]. Moreover, researchers found that a single intramuscular dose of 600,000 IU vitamin D2 could correct vitamin D deficiency, but it could not reach vitamin D sufficiency [ 27 ]. Taking all this into account, we adopted a monthly intramuscular 600,000 IU vitamin D2 to reach vitamin D sufficiency in the very elderly Chinese people with vitamin D deficiency.…”

Section: Discussionmentioning

confidence: 99%

“…Vitamin D2 treatment has been associated with a decrease in the serum level of 25(OH)D3 [ 27 ]. It was postulated to be the response to increased total 25(OH)D following vitamin D2 supplementation because a decrease in the serum level of 25(OH)D2 was also observed after vitamin D3 treatment [ 36 ].…”

Section: Discussionmentioning

confidence: 99%

“…Vitamin D3 injection, however, is not always commercially available as a pharmaceutical preparation [ 25 ]. Thus far, studies regarding intramuscular high-dose vitamin D supplementation have focused more on vitamin D3 [ 20 , 21 ] than on vitamin D2 [ 26 , 27 ], with the latter being evaluated only for the outcome of a single dose. Furthermore, there has been no common agreement worldwide to define a standard dose of vitamin D2 injection for the treatment and prevention of vitamin D deficiency.…”

Section: Introductionmentioning

confidence: 99%

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Effects of Monthly Intramuscular High-Dose Vitamin D2 on Serum 25-Hydroxyvitamin D and Immune Parameters in Very Elderly Chinese Patients with Vitamin D Deficiency

Bian

Xue

Shou

2021

International Journal of Endocrinology

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Purpose. Vitamin D deficiency is highly prevalent among the very elderly and is associated with a wide variety of clinical conditions other than musculoskeletal diseases. This study aims to ascertain the efficacy and safety of high-dose intramuscular vitamin D2 in very elderly Chinese patients with vitamin D deficiency. Methods. Very elderly (aged 80 years or over) Chinese patients with vitamin D deficiency were recruited to receive monthly intramuscular injections of 600,000 IU vitamin D2 until their serum 25-hydroxyvitamin D (25(OH)D) reached ≥30 ng/mL. The serum levels of 25(OH)D2, 25(OH)D3, iPTH, BTMs, immune parameters, and other biochemical parameters were measured at baseline and one month after each dose. Results. Of the 30 very elderly Chinese patients who had been recruited into the study, 27 (90.0%) had their vitamin D deficiency corrected, and 26 (86.7%) reached vitamin D sufficiency. The mean time (±SD) was 3.1 (±1.3) months for vitamin D deficiency to be corrected, and 6.1 (±0.8) months for vitamin D sufficiency to be reached. The mean (±SD) serum level of 25(OH)D2 increased from 0.69 (±1.51) ng/mL to 29.07 (±5.68) ng/mL, while the mean (±SD) serum level of 25(OH)D3 decreased from 9.82 (±2.75) ng/mL to 5.30 (±3.09) ng/mL (both P < 0.001 ). The total T cells in serum remained unchanged ( P > 0.05 ), and the CD4 and B cells (CD19+) were increased significantly (both P < 0.05 ). In addition, no significant change was observed in the serum levels of iPTH and BTMs. Conclusion. Monthly intramuscular injection of 600,000 IU vitamin D2 is an effective and safe dosing regimen to reach vitamin D sufficiency and enhances immune function in the very elderly Chinese patients with vitamin D deficiency.

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Section: Discussioncontrasting

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Effects of Monthly Intramuscular High-Dose Vitamin D2 on Serum 25-Hydroxyvitamin D and Immune Parameters in Very Elderly Chinese Patients with Vitamin D Deficiency

Bian

Xue

Shou

2021

International Journal of Endocrinology

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The effect of vitamin D2 supplementation on vitamin D levels in humans: A time and dose–response meta-analysis of randomized controlled trials

Zhou,

Jamilian,

Prabahar

et al. 2024

Steroids

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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

Chen

et al. 2023

Front. Endocrinol.

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BackgroundDistal 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 analysisWe 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 D2 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)D2 and 25(OH)D3 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.DiscussionGlycemic 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 registrationhttps://www.chictr.org.cn/, identifier ChiCTR2200062266.

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Long-Term Bioavailability of Single Doses of Intramuscular Vitamin D2

Cited by 3 publications

References 40 publications

Effects of Monthly Intramuscular High-Dose Vitamin D2 on Serum 25-Hydroxyvitamin D and Immune Parameters in Very Elderly Chinese Patients with Vitamin D Deficiency

Effects of Monthly Intramuscular High-Dose Vitamin D2 on Serum 25-Hydroxyvitamin D and Immune Parameters in Very Elderly Chinese Patients with Vitamin D Deficiency

The effect of vitamin D2 supplementation on vitamin D levels in humans: A time and dose–response meta-analysis of randomized controlled trials

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

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