A Study, Four Parallel Arms, Included Two Arms Open Randomisation to Different Doses of Vitamin D, for Assessment of Efficacy of Treatment With Vitamin D at Vitamin D Deficiency, Vitamin D Insufficiency and Suboptimal Levels of Vitamin D
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Level of Vitamin D at End of the Treatment Period of 12 Weeks
研究概览
简要总结
The purpose of this study is to determine the efficacy of different doses of vitamin D in persons, immigrated to Sweden from Middle East or Africa, with decreased S vitamin D.
详细描述
The participants in the study have taken part in a previous screening study. They are now asked to participate in this treatment study. At a screening visit blood samples for vitamin D3 and PTH are collected. Data regarding previous fractures, life style, exposure for sun, clothes, diet, smoking and physical activities are collected. The Vitamin D value predict the treatment dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Serum- vitamin D below 75 nmol/L
- •Men and female
- •25-65 years of age
- •Born in Middle East or Africa, living in Umeå district
排除标准
- •Hypersensitive to Cholecalciferol, cocos oil, palm kernel or rubber
- •Serum D3 equal to or above75 nmol/L
- •Hypercalcemia
- •Renal insufficiency
- •History of Kidney Calculi
- •Nephrocalcinosis
- •History of sarcoidosis and other Granulomatous Diseases
- •Known malignancy
- •Ongoing treatment with phenytoin, barbiturates, rifampicin, isoniazid
- •Ongoing treatment with cardiac glycosides
- •Ongoing treatment with thiazides
- •Ongoing treatment with Etalpha, Rocaltrol, ergocalciferol, Dygratal
- •Ongoing treatment with drugs involving fat absorption; Orlistat Colestyramin
- •Oral treatment with glucocorticoids
- •Ongoing treatment with Aluminum Compounds drugs
- •Ongoing treatment with Omega -3, vitamin D and/or calcium
- •Immobilisation
- •Other medial reason not to participate according to the investigator
- •Pregnancy (women with S-D3 below 25 nmol/)
- •Breastfeeding
研究组 & 干预措施
Group 1
Vitamin D3, 10 000 IU daily. Treatment to patients with Serum-vitamin D levels below 25 nmol/L
干预措施: Cholecalciferol high dose at Vitamin D deficiency (Drug)
Group 2a
Vitamin D3 2000 IU daily, one of two arms that patients with Serum-vitamin D levels between 25 nmol/L and 49 nmol/l will be randomised to
干预措施: Cholecalciferol median dose at Vitamin D insufficiency (Drug)
Group 2b
Vitamin D3 2000 IU weekly, one of two arms that patients with Serum-vitamin D levels between 25 nmol/L and 49 mol/l will be randomised to
干预措施: Cholecalciferol low dose at Vitamin D deficiency (Drug)
Group 3
Vitamin D3, 2000 IU daily i.e. 3 drops orally once daily for 12 weeks, treatment to patients with Serum-vitamin D levels between 50 and 74 nmol/L
干预措施: Cholecalciferol median dose at sufficient Vitamin D level (Drug)
结局指标
主要结局
Level of Vitamin D at End of the Treatment Period of 12 Weeks
时间窗: End of treatment period 12 weeks after baseline
Serum Vitamin D, 25-(OH)D
Serum-vitamin D
时间窗: Baseline
Levels of serum vitamin D3
次要结局
未报告次要终点
研究者
Margareta Norberg
M.D. Ph.D.
Umeå University