2024-511889-36-01撤回3 期
A PHASE III OPEN LABEL STUDY CONTROLLED BY VITAMIN D3 SUPPLEMENTATION AND THE DIFFERENCES BETWEEN YOUNG ADULTS AND SENIOR POPULATION
Fakultni Nemocnice Plzen1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年10月25日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Primary e nd point is Serum 25 hydroxycholecalciferol.
研究概览
简要总结
The main objective of this study is to compare the efficacy of vitamin D3 supplementation in the young and elderly population with the same dosing schedule and to develop an effective supplementation model for each age group based on the differences found.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •I ndividuals who agreed to participate without any excluding conditions
- •Age 20 27 or 65 85 years
- •Women of childbearing potential ( must use highly effective contraception for the duration of the study
- •BMI 18,5 and <30
排除标准
- •Recent vitamin D supplementation (in the past two months and during the study)
- •Hypercalcemia
- •Renal osteodystrophy with hypercalcemia
- •Current therapy with thiazide diuretic s
- •Current therapy with corticosteroids
- •Women who are pregnant, breastfeeding and planning a pregnancy at the time of the study
- •Endocrine disease or any medical condition with presumed autoimmune background (rheumatoid diseases, etc)
- •Vitamin D levels 200 nmol/L 9 Malabsorption syndromes 10 Any type or staging of malignancy 11 Any condition limiting the life expectancy to less than 12 months 12 Calcium levels over 2,75 mmol/l 1 3 Phosphate levels over 1,5 mmol/l
- •A llergy to cholecalciferol or any other component of Vigantol
结局指标
主要结局
Primary e nd point is Serum 25 hydroxycholecalciferol.
Primary e nd point is Serum 25 hydroxycholecalciferol.
次要结局
- Secondary e nd p oints are Serum 24,25 dihydroxycholecalciferol levels and Serum 3 epi 25 hydroxycholecalciferol levels.
研究者
MUDr. Hatakova Hedvika
Scientific
Fakultni Nemocnice Plzen
研究点 (1)
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