Knowledge Innovation Project of CAS - Genetic and Nutritional Association Studies on Metabolism-related Diseases in Chinese Population -- Vitamin D Intervention Study：A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- 25-hydroxyvitamin D
研究概览
简要总结
To determine the dose-response between the doses of vitamin D3 supplements and raised serum levels of 25(OH)D and also the dose of vitamin D3 required to achieve circulating 25(OH)D ≥ 75 nmol/L;
详细描述
Recent epidemiological studies suggested that serum 25-hydroxyvitamin D [25(OH)D] concentration ≥75 nmol/L appeared to be optimal for preventing cardiometabolic diseases and improving bone health. To achieve this goal, a daily intake of 1000 IU or equivalent amount from other sources, is needed, which is twice as much as the RDA recommended by Chinese Nutrition Society. Meanwhile,epidemiological evidences show that large proportions of Chinese may suffer vitamin D insufficiency or deficiency whereas the current RDA in China might be too low to provide adequate vitamin D for people's health.
In order to fill up this gap, therefore, it is essential to determine the dose-response between the doses of vitamin D3 supplements and raised serum levels of 25(OH)D and also the dose of vitamin D3 required to achieve circulating 25(OH)D ≥ 75 nmol/L.Ultimately, the current study will provide important evidence for establishing optimal vitamin D requirement for Chinese people
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 20-45 years. with vitamin D deficiency (25(OH)D < 50 nmol/l)
排除标准
- •BMI < 18.5 kg/m2, or BMI ≥ 25 kg/m2
- •Total intake of calcium from diet or supplements >1200mg/d, or fasting serum calcium level ≥2.75 mmol/l
- •Participating in other clinical studies within previous 3 months
- •Taking vitamin D supplements within previous 3 months
- •Using medications that may affect vitamin D metabolism in previous 3 months;
- •Concomitant with clinical conditions, like liver dysfunction (serum alanine transaminase (ALT) ≥40 U/L; and/or aspartate transaminase (AST) ≥40 U/L; Glutamyl transpeptidase （GGT）≥50 U/L; serum creatinine < 50 or > 120 µmol/L; urea nitrogen (UN) < 7 or > 18 mg/dl, and/or urine acid <90 or >420 µmol/L; which may affect vitamin D metabolism;
- •History of drug or alcohol abuse (>40 g/d)
- •Women during pregnancy or lactation
- •Individuals with mental disorders or current use of antidepressants, the conditions which may affect him or her understanding and unwillingness to the intervention;
- •Having clinically diagnosed AIDS, hepatitis A, hepatitis B, tuberculosis and other infectious diseases.
研究组 & 干预措施
Placebo
5 placebo pills per day, 16 weeks
干预措施: Placebo (Dietary Supplement)
400 IU
(4 placebo pills + 1 vitamin D pill) per day, 16 weeks
干预措施: Placebo (Dietary Supplement)
800 IU
(3 placebo pills + 2 vitamin D pills) per day, 16 weeks
干预措施: Placebo (Dietary Supplement)
1200 IU
(2 placebo pills + 3 vitamin D pills) per day, 16 weeks
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
25-hydroxyvitamin D
时间窗: 16 weeks
Serum 25(OH)D concentration will be assayed by utilizing a liquid chromatography-mass spectrometry (LC-MS) method
次要结局
- creatinine(16 weeks)
- aspartate aminotransferase(AST)(16 weeks)
- urea nitrogen(16 weeks)
- calcium(16 weeks)
- glutamyl transpeptidase（GGT）(16 weeks)
- uric acid(16 weeks)
- parathyroid hormone（PTH）(16 weeks)
- alanine aminotransferase（ALT)(16 weeks)
- phosphate(16 weeks)
研究者
Xu Lin
Principal Investigator
Chinese Academy of Sciences