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临床试验/NCT01462058
NCT01462058已完成4 期

The Role of Vitamin D Supplementation on Well Being and Symptoms of Depression During the Winter Season in Health Service Staff

Connie Thuree Nielsen, consultant, MD, ph.d1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2011年10月最近更新:
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
50
试验地点
1
主要终点
Hamilton-29

研究概览

简要总结

The purpose of this study is to investigate whether vitamin D3 (70 micrograms) is better than placebo in preventing depression symptoms among employees in health care

详细描述

Vitamin D3 is produced in the skin after exposure to ultraviolet B light from the sun. Vitamin D3 is metabolised sequential in the liver into 25-hydroxy-vitamin D [25(OH)D], which is the storage form of vitamin D in the body, and then in the kidney into the steroid hormone, 1a,25-dihydroxyvitamin 1a,25-dihydroxyvitamin D [1,25(OH)2D].

At higher latitudes ultraviolet B light is stopped by the atmosphere during winter season. Half of Danes have low levels of [25(OH)D] in the blood and especially in the early spring months the levels of [25(OH)D] are low. In addition, Vitamin D3 is absorbed through the gut from vitamin D-rich food sources. But several studies show that it is not possible through a recommended diet, which consists of 300 g of fish per week to consume adequate amounts of vitamin D3.

New research suggests link between vitamin D3 and brain function.In the Central Nervous System (CNS) there are specific nuclear receptors for 1,25(OH)2D (VDR) and the enzymes necessary for the hydroxylation of 25(OH)D to 1,25(OH)2D are also present in CNS.

In clinical studies, low serum levels of 25(OH)D, have been associated with reduced cognitive function, anxiety and depression.

The objective of this randomized clinical trial is to investigate whether indoor employees, with tendency to depressive symptoms in the winter season, should be offered vitamin D3 supplements during the Winter season, or it has no significance in relation prevent depressive symptoms.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Health service staff and employee in the Region of Southern Denmark.
  • Tendency to depressive symptoms in the winter season SPAQ>7.

排除标准

  • clinical diagnosis sarcoidoses
  • tuberculosis
  • bipolar affective disorder
  • schizophrenia
  • hypercalcemia
  • hyperphosphatemia
  • pregnancy
  • hyperparathyroidism
  • reduced kidney function

研究组 & 干预措施

Vitamin D3

Active Comparator

one tablet of vitamin D3 (70µg) per day for 12 weeks.

干预措施: Vitamin D3 (Dietary Supplement)

placebo

Placebo Comparator

one tablet of sugar pill per day for 12 weeks.

干预措施: Placebo (Drug)

结局指标

主要结局

Hamilton-29

时间窗: 12 weeks

Change from baseline in Hamilton-29 at week 12

次要结局

  • WHO-5(12 weeks)

研究者

发起方
Connie Thuree Nielsen, consultant, MD, ph.d
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Connie Thuree Nielsen, consultant, MD, ph.d

MD, ph.d

Region Syddanmark

研究点 (1)

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