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临床试验/NCT05591170
NCT05591170已完成4 期

The Effect of Single High Dose of Vitamin D on Serum Levels of Its Metabolites

Department of Endocrinology, Centre of Postgraduate Medical Education1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2021年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
58
试验地点
1
主要终点
Changes of serum vitamin D metabolites after the administration of 120 000 IU cholecalciferol compared to control group.

研究概览

简要总结

The aim of this interventional study is to assess the effect of the single high dose of vitamin D on its serum metabolites in elderly.

The main questions it attempts to answer is:

  1. what is the effect of a single, high, oral dose of vitamin D3 (120,000 IU) on serum 25(OH)D3, 25(OH)D2, 24,25(OH)2D3, 3-epi-25(OH)D3, 1,25(OH)2D3, 24,25(OH)2D3/25(OH)D3 ratio, and 25(OH)D3/3-epi-25(OH)D3 ratio concentration at baseline, 3 days and 7 days after administration, compared to control group.
  2. what is the influence of percentage of fat tissue on serum metabolites of vitamin D and their changes after bolus dose, compared to control group.

详细描述

Vitamin D belongs to dietary micronutriens and it is known for pleiotropic actions, going far beyond its classical function of maintenance of calcium/phosphorous homeostasis. The extra-skeletal effects of vitamin D include the role in cellular proliferation, differentiation, and immune modulation. Therefore, vitamin D has become the subject of numerous studies in relation to its potential protective effect in pathophysiology of diabetes, cardiovascular diseases, autoimmune diseases, infections and cancer.

The most common form of vitamin D is 25(OH)D3 - it can be obtained by photochemical reaction in the skin and through diet via animal-based food. 25(OH)D2 may be found in some plant-based food and has lower affinity to vitamin D binding protein, therefore it has a shorter half-life in the blood. In many countries, due to insufficient skin synthesis, vitamin D has to be acquired through fortified food and supplements in different dosing schedules (e.g. once daily, once weekly). Higher doses of vitamin D taken less frequently may significantly improve patients' adherence to recommended treatment regimens. However, there are arising questions about the efficacy and safety of such interventions. 1,25(OH)2D3 is the product of 1-hydroxylation of 25(OH)D3 in kidneys and it is the active form of vitamin D with a short half-life in the blood, while 24,25(OH)2D3 is the product of the reaction of 24-hydroxylase and it is considered inactive. The measurement of serum levels of both metabolites may contribute to better understanding the mechanisms protecting against too high increase of active forms of vitamin D.

In the study, the investigators aim to establish the changes of serum vitamin D metabolites (namely 25OHD, 25(OH)D3, 24,25(OH)2D3, 25(OH)D2, 3-epi-25(OH)D3 and 1,25(OH)2D3) and chosen ratios after oral administration of 120 000 IU of vitamin D 3 days and 7 days after the intervention in hospitalized elderly patients. The investigators also address a question if the change of serum vitamin D metabolites after single high dose of vitamin D3 is dependent on the body fat percentage and severity of vitamin D deficiency. Quantitative analyses were performed using liquid chromatography with tandem mass spectrometry (LC-MS/MS).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • written, informed consent,
  • age ≥ 60 years-old,
  • admission to the hospital due to emergency reasons.

排除标准

  • hypercalcemia,
  • nephrolithiasis,
  • kidney insufficiency,
  • documented vitamin D3 metabolism disorders such as sarcoidosis, parathyroid disease or genetic defects,
  • vitamin D3 supplementation within 6 months prior to the hospitalisation.

研究组 & 干预措施

Study Group

Experimental

Participants received single, high, oral dose of vitamin D3 (120,000 IU), serum 25(OH)D3, 25(OH)D2, 24,25(OH)2D3, 3-epi-25(OH)D3, 1,25(OH)2D3, 24,25(OH)2D3/25(OH)D3 ratio, and 25(OH)D3/3-epi-25(OH)D3 ratio concentration (measured by LC-MS/MS) at baseline, 3 days and 7 days after bolus dose were measured.

The percentage of fat tissue was determined using Dual-Energy X-Ray Absorptiometry (DXA).

干预措施: Cholecalciferol 120 000 IU (Drug)

结局指标

主要结局

Changes of serum vitamin D metabolites after the administration of 120 000 IU cholecalciferol compared to control group.

时间窗: Measurements at baseline, 3 days and 7 days after.

Changes of serum 25(OH)D3, 25(OH)D2, 24,25(OH)2D3, 3-epi-25(OH)D3, 1,25(OH)2D3, 24,25(OH)2D3/25(OH)D3 ratio, and 25(OH)D3/3-epi-25(OH)D3 ratio concentration at baseline, 3 days and 7 days after the intervention, compared to control group.

次要结局

  • Influence of percentage of fat tissue on serum concentration of metabolites of vitamin D and their changes after bolus dose.(Dual-Energy X-Ray Absorptiometry (DXA) at baseline, measurements of vitamin D metabolites at baseline, 3 days and 7 days after.)

研究者

发起方
Department of Endocrinology, Centre of Postgraduate Medical Education
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dorota Lesczyńska

MD

Department of Endocrinology, Centre of Postgraduate Medical Education

研究点 (1)

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